FDA Product Code
FDA Product Code IYO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1560
510(k) Clearances — 895 records · page 7 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K891225 | OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 | Canon USA, Inc. | 1989-05-31 | Traditional | PDF ↗ |
| K891309 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1989-05-16 | Traditional | PDF ↗ |
| K891386 | CVIS ULTRA-SCAN ONE IMAGING SYSTEM | Cardiovascular Imaging Systems, Inc. | 1989-05-16 | Traditional | PDF ↗ |
| K890969 | TRANSESOPHAGEAL TRANSDUCER PEF-511SA | Toshiba Medical Systems | 1989-05-16 | Traditional | PDF ↗ |
| K890772 | ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. | Boston Scientific Corp | 1989-05-10 | Traditional | PDF ↗ |
| K890519 | LABSONICS MAMM-O-MATE MODEL NO. 918084-1 | Laboratory Equipment Corp. | 1989-05-03 | Traditional | PDF ↗ |
| K890173 | INTERSPEC APOGEE | Interspec, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K883917 | NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT | Sonomed Technology, Inc. | 1989-03-31 | Traditional | PDF ↗ |
| K885228 | RT6800 ECHOCARDIOGRAPHY SYSTEM | General Electric Co. | 1989-03-14 | Traditional | PDF ↗ |
| K881336 | BRYMASCAN-A | Brymill Corp. | 1989-03-14 | Traditional | PDF ↗ |
| K883359 | DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A | Toshiba Medical Systems | 1989-01-25 | Traditional | PDF ↗ |
| K884632 | ACUSON I5100 ULTRASOUND TRANSDUCER | Acuson Corp. | 1989-01-13 | Traditional | PDF ↗ |
| K884395 | HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS | Hewlett-Packard Co. | 1989-01-10 | Traditional | PDF ↗ |
| K884299 | APA-C CATALOG NUMBER A-8001-C | Ausonics Pty , Ltd. | 1989-01-10 | Traditional | PDF ↗ |
| K884595 | OPHTHASCAN MINI-B | Biophysic Medical, Inc. | 1989-01-03 | Traditional | PDF ↗ |
| K883925 | UROIMAGER | Ausonics Pty , Ltd. | 1988-12-15 | Traditional | PDF ↗ |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | Ausonics Pty , Ltd. | 1988-12-14 | Traditional | PDF ↗ |
| K875187 | SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Corp. | 1988-12-12 | Traditional | PDF ↗ |
| K883752 | ACUSON L538 TRANSDUCER | Acuson Corp. | 1988-12-01 | Traditional | PDF ↗ |
| K881140 | ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY | Advanced Technology Laboratories, Inc. | 1988-11-29 | Traditional | PDF ↗ |
| K883481 | HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE | Hewlett-Packard Co. | 1988-11-04 | Traditional | PDF ↗ |
| K882478 | 100-01778-52 ULTRASOUND SYSTEM | Diasonics, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K883546 | TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER | Advanced Technology Laboratories, Inc. | 1988-10-07 | Traditional | PDF ↗ |
| K883965 | PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR | Teknar, Inc. | 1988-10-05 | Traditional | PDF ↗ |
| K881889 | CANON IOL ESTIMATOR KU-1 | Canon USA, Inc. | 1988-09-15 | Traditional | PDF ↗ |
| K881850 | TEKNAR PERCU-SCAN | Teknar, Inc. | 1988-08-29 | Traditional | PDF ↗ |
| K874854 | GPS/WGPS/PREVIEW GP | Labsonics, Inc. | 1988-08-25 | Traditional | PDF ↗ |
| K881834 | MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Medical Systems Information Technologies | 1988-08-24 | Traditional | PDF ↗ |
| K883238 | GENESIS II TRANSCRANIAL PROBE | Biosound, Inc. | 1988-08-24 | Traditional | PDF ↗ |
| K882162 | NIDEK US-3000 | Nidek, Inc. | 1988-08-19 | Traditional | PDF ↗ |
| K882959 | ENDOVAGINAL PROBE, SMS-510VA | Toshiba Medical Systems | 1988-08-18 | Traditional | PDF ↗ |
| K882805 | CILCO VILLASENOR PACHYMETER | Coopervision-Cilco | 1988-08-12 | Traditional | PDF ↗ |
| K873452 | MODIFIED MODEL SSD-650 SYSTEM | Ge Medical Systems Information Technologies | 1988-07-28 | Traditional | PDF ↗ |
| K874192 | MULTIPURPOSE TRANSDUCER RANGE | Pie Data Medical BV | 1988-07-19 | Traditional | PDF ↗ |
| K875357 | BIOPSY FIXATION UNIT-TYPE UA 0997 | Bruel & Kjaer Industri A/S | 1988-07-01 | Traditional | PDF ↗ |
| K874211 | EUB-450 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1988-06-23 | Traditional | PDF ↗ |
| K874028 | ACUSON S328 TRANSDUCER | Acuson Computed Sonography | 1988-06-21 | Traditional | PDF ↗ |
| K881605 | BIOPSY GUIDE | Teknar, Inc. | 1988-06-21 | Traditional | PDF ↗ |
| K880839 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM | Phoenix Imaging | 1988-06-10 | Traditional | PDF ↗ |
| K880580 | EXTENDED MULTIPURPOSE TRANSDUCER RANGE | Pie Medical USA BV | 1988-06-08 | Traditional | PDF ↗ |
| K881208 | PROBE SHEATH FOR ADMS ULTRASOUND PROBE | Advanced Diagnostic Medical Systems, Inc. | 1988-05-16 | Traditional | PDF ↗ |
| K875251 | ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE | Philips Medical Systems (Cleveland), Inc. | 1988-05-11 | Traditional | PDF ↗ |
| K874363 | ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI. | Acuson Computed Sonography | 1988-05-02 | Traditional | PDF ↗ |
| K881028 | 7.5 MHZ ENDORECTAL PROBE | Philips Ultrasound, Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | Carolina Medical Electronics | 1988-04-25 | Traditional | PDF ↗ |
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | Carolina Medical Electronics | 1988-04-25 | Traditional | PDF ↗ |
| K880714 | DIASONICS QT ENDORECTAL 7.5 MHZ PROBE | Diasonics, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K874548 | SIM 4000C | Ote-Biomedica Elettronica S.P.A | 1988-04-18 | Traditional | PDF ↗ |
| K874683 | THE ESI-2000 ULTRASOUND UNIT | Elscint, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K875128 | TRANS/R NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-15 | Traditional | PDF ↗ |
| K875240 | TRANS/V NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-15 | Traditional | PDF ↗ |
| K875236 | TRANS/P NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-15 | Traditional | PDF ↗ |
| K875241 | CIVCO SEED IMPLANT NEEDLE GUIDE | CIVCO Medical Instruments Co., Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K880659 | TEKNAR PROSCAN ACCESSORY PROBE | Teknar, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K873845 | SIM 4000I | Ote-Biomedica Elettronica S.P.A | 1988-04-07 | Traditional | PDF ↗ |
| K880219 | TRANSRECTAL PROBE BD65S-TR | Elscint, Inc. | 1988-03-31 | Traditional | PDF ↗ |
| K873937 | SDR 3500 (PHILIPS PLATINUM +) | Philips Ultrasound, Inc. | 1988-03-23 | Traditional | PDF ↗ |
| K880065 | NIDEK UP-2000 | Nidek, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K880081 | VISION CARE/PHAKOSYSTEMS ECHOPACH | Phakosystems, Inc. | 1988-03-15 | Traditional | PDF ↗ |
| K873159 | COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER | Cone Instruments, Inc. | 1988-03-01 | Traditional | PDF ↗ |
| K872288 | SONOLAYER-V, SAL-38B | Toshiba Medical Systems | 1988-01-11 | Traditional | PDF ↗ |
| K871004 | EUB-410 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1987-12-11 | Traditional | PDF ↗ |
| K872726 | DGH-3000A A-SCAN | Dgh Technology, Inc. | 1987-12-04 | Traditional | PDF ↗ |
| K871938 | VISION CARE/PHAKOSYSTEMS ECHORULE | Phakosystems, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K873096 | COLOR FLOW IMAGING | Advanced Technology Laboratories, Inc. | 1987-11-23 | Traditional | PDF ↗ |
| K872307 | VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB | General Electric Co. | 1987-09-08 | Traditional | PDF ↗ |
| K871536 | OPHTHASONIC A-SCAN/ B-SCAN | Teknar, Inc. | 1987-08-26 | Traditional | PDF ↗ |
| K854654 | SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 | Philips Medical Systems, Inc. | 1987-08-19 | Traditional | PDF ↗ |
| K872027 | OLYMPUS GF-UM2/EU-M2 | Olympus Corp. | 1987-08-17 | Traditional | PDF ↗ |
| K864807 | TEKNAR PROSCAN(TM) | Teknar, Inc. | 1987-07-10 | Traditional | PDF ↗ |
| K870964 | ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER | Elscint, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K860581 | QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM | Quantum Medical Systems, Inc. | 1987-02-13 | Traditional | PDF ↗ |
| K864336 | PACHYMETER SYSTEM V | CooperVision, Inc. | 1987-01-09 | Traditional | PDF ↗ |
| K863947 | SONOLAYER-L, SAL-77B | Toshiba Medical Systems | 1987-01-09 | Traditional | PDF ↗ |
| K862867 | EUB-310 ULTRASONIC SCANNER | Hitachi Medical Corp. of America | 1987-01-05 | Traditional | PDF ↗ |
| K863780 | ADA-1000 (ADVANCED DIGITAL ARRAY) | Diasonics, Inc. | 1986-12-29 | Traditional | PDF ↗ |
| K860757 | OPHTHASONIC A-SCAN | Teknar, Inc. | 1986-12-18 | Traditional | PDF ↗ |
| K864398 | STORZ SOLID & ANGLED SOLID CONTACT PROBES | Storz Instrument Co. | 1986-12-18 | Traditional | PDF ↗ |
| K863576 | EUB-400 DIAGNOSTIC ULTRASOUND DEVICE | Hitachi Medical Corp. of America | 1986-12-12 | Traditional | PDF ↗ |
| K862127 | DYMAX PERSONAL SCANNER | Dymax Corp | 1986-12-11 | Traditional | PDF ↗ |
| K862165 | ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340 | Hitachi Medical Corp. of America | 1986-11-28 | Traditional | PDF ↗ |
| K863338 | 7.5 MHZ LINEAR SMALL PARTS PROBE | Siemens Medical Solutions USA, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K863041 | 3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306 | Siemens Medical Solutions USA, Inc. | 1986-11-10 | Traditional | PDF ↗ |
| K863043 | 3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305 | Siemens Medical Solutions USA, Inc. | 1986-11-10 | Traditional | PDF ↗ |
| K863096 | 5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307 | Siemens Medical Solutions USA, Inc. | 1986-11-10 | Traditional | PDF ↗ |
| K862164 | EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER | Hitachi Medical Corp. of America | 1986-11-04 | Traditional | PDF ↗ |
| K852502 | AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 | Bruel & Kjaer Industri A/S | 1986-10-23 | Traditional | PDF ↗ |
| K862151 | COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF | Hewlett-Packard Co. | 1986-09-19 | Traditional | PDF ↗ |
| K854653 | CILCO SONOMETRICS DIGICON | CooperVision, Inc. | 1986-09-04 | Traditional | PDF ↗ |
| K861538 | 860 COLOR DOPPLER OR COLORVIEW 860 | Ge Medical Systems Information Technologies | 1986-08-25 | Traditional | PDF ↗ |
| K862166 | SONORANGER | Ausonics Pty , Ltd. | 1986-08-18 | Traditional | PDF ↗ |
| K860697 | ULTRASOUND IMAGING SYSTEM MODEL 280 SL | Johnson & Johnson Professionals, Inc. | 1986-07-24 | Traditional | PDF ↗ |
| K862681 | ULTRAMARK 1 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K860123 | 5.0 MHZ INTRAOPERATIVE ARRAY | Siemens Medical Solutions USA, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K861376 | COMBISON R 320A | Cone Instruments, Inc. | 1986-07-03 | Traditional | PDF ↗ |
| K861335 | STORZ COMPUSCAN 68K | Storz Instrument Co. | 1986-06-30 | Traditional | PDF ↗ |
| K853565 | ARTIS ULTRASOUND IMAGING SYSTEM | Philips Medical Systems (Cleveland), Inc. | 1986-06-30 | Traditional | PDF ↗ |
| K860081 | ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS | Elscint, Inc. | 1986-06-16 | Traditional | PDF ↗ |
| K854959 | LINEAR SCANNER PROBE, MODEL TL-50 | Elscint, Inc. | 1986-06-16 | Traditional | PDF ↗ |
| K854389 | NIDEK US-1600 A-SCAN | Nidek, Inc. | 1986-04-08 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.