FDA Product Code
FDA Product Code ITX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1570
510(k) Clearances — 415 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K912088 | BIOPSY ACCESSORIES FOR ULTRASOUND PROBES | Biosound, Inc. | 1991-12-05 | Traditional | PDF ↗ |
| K912361 | SI-450/ILUS (INTRALUMINAL ULTRASOUND) | Siemens Ultrasound, Inc. | 1991-12-02 | Traditional | PDF ↗ |
| K912600 | INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER | Intertherapy, Inc. | 1991-11-19 | Traditional | PDF ↗ |
| K911114 | INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM | Interson Corp. | 1991-11-19 | Traditional | PDF ↗ |
| K911767 | ACUSON V510 TRANSDUCER | Acuson Corp. | 1991-10-31 | Traditional | PDF ↗ |
| K911043 | HEMISPHERE MULTIPLANE ENDORECTAL PROBE | Pie Medical Equipment B.V. | 1991-10-09 | Traditional | PDF ↗ |
| K911044 | 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) | Pie Medical Equipment B.V. | 1991-10-07 | Traditional | PDF ↗ |
| K911414 | CVIS INSIGHT IMAGING CATHETERS | Cardiovascular Imaging Systems, Inc. | 1991-09-11 | Traditional | PDF ↗ |
| K912363 | ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 | Hitachi Medical Corp. of America | 1991-08-27 | Traditional | PDF ↗ |
| K903984 | CW DOPPLER/4.5 MHZ | Diasonics, Inc. | 1991-06-14 | Traditional | PDF ↗ |
| K911073 | PROBE REFILL KIT | Interspec, Inc. | 1991-06-06 | Traditional | PDF ↗ |
| K911309 | UST-974-5 CONVEX TRANSDUCER | Ge Medical Systems Information Technologies | 1991-04-29 | Traditional | PDF ↗ |
| K900880 | OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12 | Olympus Corp. | 1991-04-29 | Traditional | PDF ↗ |
| K910268 | TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T | Hitachi Medical Corp. | 1991-04-15 | Traditional | PDF ↗ |
| K904459 | C544 TRANSDUCER | Acuson Corp. | 1991-03-29 | Traditional | PDF ↗ |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | Parexel Intl. Corp. | 1991-03-26 | Traditional | PDF ↗ |
| K904902 | SMA 26 TRANSDUCER | Parexel Intl. Corp. | 1991-03-26 | Traditional | PDF ↗ |
| K910669 | 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU | Siemens Ultrasound, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K910529 | 7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS | Siemens Ultrasound, Inc. | 1991-03-15 | Traditional | PDF ↗ |
| K903561 | QUICK-CLIP NEEDLE GUIDE | Acuson Corp. | 1991-03-05 | Traditional | PDF ↗ |
| K905535 | ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER | Ge Medical Systems Information Technologies | 1991-02-28 | Traditional | PDF ↗ |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | Ausonics Pty , Ltd. | 1991-02-13 | Traditional | PDF ↗ |
| K905252 | ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Ge Medical Systems Information Technologies | 1991-02-12 | Traditional | PDF ↗ |
| K905391 | UST-969-5 CONVEX TRANSDUCER | Ge Medical Systems Information Technologies | 1991-01-31 | Traditional | PDF ↗ |
| K904665 | MODEL IW17.5A INTRA OPERATIVE TRANSDUCER | Kretztechnik AG | 1991-01-11 | Traditional | PDF ↗ |
| K902926 | COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM | Philips Medical Systems North America, Inc. | 1990-11-26 | Traditional | PDF ↗ |
| K902245 | SONICATH(TM) 9F, 12 MHZ | Boston Scientific Corp | 1990-10-09 | Traditional | PDF ↗ |
| K900155 | INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER | Interspec, Inc. | 1990-10-05 | Traditional | PDF ↗ |
| K900683 | SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND | Hitachi Medical Corp. of America | 1990-08-31 | Traditional | PDF ↗ |
| K902070 | RADIUS AND SONOCHROME | General Electric Co. | 1990-08-28 | Traditional | PDF ↗ |
| K897073 | ADDITIONAL TRANSDUCERS FOR USE W/SDL 300 | Shimadzu Corp. | 1990-08-21 | Traditional | PDF ↗ |
| K896644 | ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 | Shimadzu Corp. | 1990-08-21 | Traditional | PDF ↗ |
| K901725 | ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A | Kretztechnik AG | 1990-08-15 | Traditional | PDF ↗ |
| K901655 | 1 TRANSDUCER FOR COMBISON 310A | Kretztechnik AG | 1990-07-20 | Traditional | PDF ↗ |
| K893863 | ACUSON L538 TRANSDUCER | Acuson Computed Sonography | 1990-05-23 | Traditional | PDF ↗ |
| K894763 | FUJINON EDU SYSTEM | Fujinon, Inc. | 1990-05-22 | Traditional | PDF ↗ |
| K900555 | INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA. | Interson Corp. | 1990-05-02 | Traditional | PDF ↗ |
| K896038 | B-SCAN 10 MHZ PROBE | Teknar, Inc. | 1990-04-23 | Traditional | PDF ↗ |
| K890532 | EUP-C321 5.0MHZ CONVEX TYPE PROBE | Hitachi Medical Corp. of America | 1990-04-13 | Traditional | PDF ↗ |
| K890531 | EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE | Hitachi Medical Corp. of America | 1990-04-13 | Traditional | PDF ↗ |
| K897098 | SIEMENS ENDO-P-PROBE | Siemens Medical Solutions USA, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K894547 | RADIUS CF | General Electric Co. | 1989-11-22 | Traditional | PDF ↗ |
| K895359 | ADMS MULTIPLANE RECTAL PROBE | Avalon Technology Corp. | 1989-11-22 | Traditional | PDF ↗ |
| K895100 | ECHO GEL (RAINFOREST) | Lead-Lok, Inc. | 1989-11-03 | Traditional | PDF ↗ |
| K874943 | SONAR-AID(R) ULTRASOUND STANDOFF PAD | Geistlich-Pharma | 1988-07-25 | Traditional | PDF ↗ |
| K874922 | ACUSON TRANSPERINEAL NEEDLE GUIDE | Acuson Computed Sonography | 1988-02-19 | Traditional | PDF ↗ |
| K874860 | ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA. | Acuson Computed Sonography | 1988-02-17 | Traditional | PDF ↗ |
| K870899 | EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX | Biosound, Inc. | 1987-12-30 | Traditional | PDF ↗ |
| K870967 | ADMS TRANSRECTAL 7.5 MHZ PROBE | Diasonics, Inc. | 1987-09-29 | Traditional | PDF ↗ |
| K871432 | 3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW | Advanced Technology Laboratories, Inc. | 1987-08-07 | Traditional | PDF ↗ |
| K863269 | SONOLAYER - V, SSA-100A. | Toshiba Medical Systems | 1987-07-22 | Traditional | PDF ↗ |
| K871609 | ULTRASOUND TRANSDUCER SHEATHS, STERILE | Amedic USA | 1987-07-15 | Traditional | PDF ↗ |
| K870748 | 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE | Philips Ultrasound, Inc. | 1987-04-10 | Traditional | PDF ↗ |
| K870038 | TRT TRANS-RECTAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1987-03-30 | Traditional | PDF ↗ |
| K863708 | 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12 | Siemens Medical Solutions USA, Inc. | 1987-03-23 | Traditional | PDF ↗ |
| K864812 | DIASONICS SPA 3.5 MHZ, 30MM PROBE | Diasonics, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K864758 | DIASONICS SPA 5.O 27MM PROBE | Diasonics, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K864222 | SERIES 620 RECTAL PROBE COVER | General Electric Co. | 1987-03-04 | Traditional | PDF ↗ |
| K862686 | KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM | Kontron Instruments, Inc. | 1987-02-27 | Traditional | PDF ↗ |
| K863364 | DIAGNOSTIC ULTRASONIC TRANSDUCER | Toshiba Medical Systems | 1987-02-27 | Traditional | PDF ↗ |
| K855247 | INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER | Codman & Shurtleff, Inc. | 1987-02-19 | Traditional | PDF ↗ |
| K863700 | RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE | General Electric Co. | 1987-02-10 | Traditional | PDF ↗ |
| K864135 | 280SL IMAGING SYSTEM SMALL PARTS PROBES | Ge Medical Systems Information Technologies | 1987-01-27 | Traditional | PDF ↗ |
| K864136 | 260SL IMAGING SYSTEM SMALL PARTS PROBES | Ge Medical Systems Information Technologies | 1987-01-27 | Traditional | PDF ↗ |
| K862211 | ULTRASOUND TRANSDUCER ASSEMBLY | Johnson & Johnson Professionals, Inc. | 1987-01-02 | Traditional | PDF ↗ |
| K862844 | 7.5 MHZ LINEAR PROBE, CAT. NO. H4221H | General Electric Co. | 1986-11-25 | Traditional | PDF ↗ |
| K862911 | BI-PLANE TRANSRECTAL PROBE NUMBER H4221T | General Electric Co. | 1986-10-31 | Traditional | PDF ↗ |
| K860009 | 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM | Johnson & Johnson Professionals, Inc. | 1986-08-20 | Traditional | PDF ↗ |
| K860568 | ULTRASONIC IMAGING SYSTEM (MODIFIED) | Interspec, Inc. | 1986-08-11 | Traditional | PDF ↗ |
| K861358 | PS SYSTEM WITH SD-200 DOPPLER | Johnson & Johnson Professionals, Inc. | 1986-07-30 | Traditional | PDF ↗ |
| K860531 | SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS | Toshiba Medical Systems | 1986-07-18 | Traditional | PDF ↗ |
| K861237 | VASOVIEW DUPLEX IMAGING SYSTEM | Sonicaid, Inc. | 1986-07-14 | Traditional | PDF ↗ |
| K861109 | CW DOPPLER STATIC TRANSDUCERS | Advanced Technology Laboratories, Inc. | 1986-07-08 | Traditional | PDF ↗ |
| K861228 | 7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER) | General Electric Co. | 1986-07-03 | Traditional | PDF ↗ |
| K854337 | SDL-300 | Shimadzu Corp. | 1986-06-20 | Traditional | PDF ↗ |
| K860553 | STORZ, ALPHA II BIOMETRIC RULER | Storz Instrument Co. | 1986-06-16 | Traditional | PDF ↗ |
| K860361 | DIASONICS 3.5 GWA 30MM PROBE | Diasonics, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K860281 | CONVEX PROBE, PVE-382M | Toshiba Medical Systems | 1986-05-27 | Traditional | PDF ↗ |
| K860235 | MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER | Hoffrel Instruments, Inc. | 1986-05-15 | Traditional | PDF ↗ |
| K843247 | KOI PACHYMETER | Koi, Inc. | 1986-04-30 | Traditional | PDF ↗ |
| K844772 | 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU | Philips Medical Systems, Inc. | 1986-04-17 | Traditional | PDF ↗ |
| K860494 | 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T | Ausonics Pty , Ltd. | 1986-03-26 | Traditional | PDF ↗ |
| K854787 | ACUSON L538 TRANSDUCER | Acuson Computed Sonography | 1986-03-03 | Traditional | PDF ↗ |
| K853966 | ACUSON L312 TRANSDUCER | Acuson Computed Sonography | 1986-02-20 | Traditional | PDF ↗ |
| K854429 | ACUSON NEEDLE GUIDE SYSTEM | Acuson Computed Sonography | 1986-02-07 | Traditional | PDF ↗ |
| K854788 | ACUSON AL538 TRANSDUCER | Acuson Computed Sonography | 1986-01-15 | Traditional | PDF ↗ |
| K854785 | ACUSON AL558 TRANSDUCER | Acuson Computed Sonography | 1986-01-15 | Traditional | PDF ↗ |
| K854786 | ACUSON BL538 TRANSDUCER | Acuson Computed Sonography | 1986-01-15 | Traditional | PDF ↗ |
| K852947 | ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M | Advanced Technology Laboratories, Inc. | 1986-01-06 | Traditional | PDF ↗ |
| K853249 | RT3600(115V) RT3600(220/240V) | General Electric Co. | 1985-12-09 | Traditional | PDF ↗ |
| K852159 | NEW OPTIONAL PROBES FOR SSA-90A | Toshiba Medical Systems | 1985-12-02 | Traditional | PDF ↗ |
| K852090 | SONOLAYER-L, SAL-77A | Toshiba Medical Systems | 1985-12-02 | Traditional | PDF ↗ |
| K853755 | ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 | Victoreen, Inc. | 1985-11-26 | Traditional | PDF ↗ |
| K853852 | MULTISCAN 7 | Multiscan, Inc. | 1985-11-19 | Traditional | PDF ↗ |
| K852974 | ACUSON RADIOLOGY DOPPLER ACCESSORY | Acuson Computed Sonography | 1985-10-24 | Traditional | PDF ↗ |
| K851526 | CONVEX PROBE, PVE-393M | Toshiba Medical Systems | 1985-09-23 | Traditional | PDF ↗ |
| K851240 | SONOLAYER-L SAL-32B | Toshiba Medical Systems | 1985-09-23 | Traditional | PDF ↗ |
| K851036 | SONOLAYER-V, SSA-90A | Toshiba Medical Systems | 1985-09-17 | Traditional | PDF ↗ |
| K852132 | MODEL 21225A CW COPPLER/IMAGING TRANSDUCER | Hewlett-Packard Co. | 1985-08-19 | Traditional | PDF ↗ |
| K844031 | SONOMED TECH OPHTHALMIC B-SCAN B-3000 | Sonomed Technology, Inc. | 1985-05-22 | Traditional | PDF ↗ |
Product code ITX · Class II · Radiology. Data: openFDA.