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 8 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K854668 | 5.0 MHZ LINEAR ARRAY SONOLINE PROBE | Siemens Medical Solutions USA, Inc. | 1986-03-20 | Traditional | PDF ↗ |
| K854667 | 7.5 MHZ LINEAR ARRAY SONOLINE PROBE | Siemens Medical Solutions USA, Inc. | 1986-03-20 | Traditional | PDF ↗ |
| K853147 | SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY | Scano, Inc. | 1986-03-13 | Traditional | PDF ↗ |
| K855124 | CONVEX PROBE, PVE-382M | Toshiba Medical Systems | 1986-03-12 | Traditional | PDF ↗ |
| K854555 | GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT | Gl Ultrasound , Ltd. | 1986-03-12 | Traditional | PDF ↗ |
| K860061 | OCULAB BIOMETRICPEN | Oculab, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K852686 | SONOLINE CD | Siemens Medical Solutions USA, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K860062 | OCULAB PACHPEN | Oculab, Inc. | 1986-03-10 | Traditional | PDF ↗ |
| K854743 | 2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE | Johnson & Johnson Professionals, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) | Cilco, Inc. | 1986-02-27 | Traditional | PDF ↗ |
| K853739 | SONOLAYER SAL-55A/55AS | Toshiba Medical Systems | 1986-02-24 | Traditional | PDF ↗ |
| K853702 | ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN | Johnson & Johnson Professionals, Inc. | 1986-02-13 | Traditional | PDF ↗ |
| K852862 | CORNEO-GAGE TWO | Sonogage, Inc. | 1986-01-30 | Traditional | PDF ↗ |
| K844112 | MYOPACH ULTRASONIC PACHOMETER | Myocure, Inc. | 1986-01-16 | Traditional | PDF ↗ |
| K853946 | SONOLINE LX | Siemens Medical Solutions USA, Inc. | 1986-01-16 | Traditional | PDF ↗ |
| K853008 | SONOLINE SL-2(ULTRASOUND SCANNER) | Siemens Medical Solutions USA, Inc. | 1986-01-13 | Traditional | PDF ↗ |
| K851972 | DIASONICS ADA400 ADVANCED DIGITAL ARRAY | Diasonics, Inc. | 1985-12-31 | Traditional | PDF ↗ |
| K853217 | QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES | Quantum Medical Systems, Inc. | 1985-12-30 | Traditional | PDF ↗ |
| K854135 | HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A | Hewlett-Packard Co. | 1985-12-23 | Traditional | PDF ↗ |
| K853311 | LINEAR ARRAY PROBE PLB-310M FOR SAL-32B | Toshiba Medical Systems | 1985-11-13 | Traditional | PDF ↗ |
| K850834 | SDL-32 ELECTRONIC LINEAR SCANNER | Shimadzu Corp. | 1985-10-31 | Traditional | PDF ↗ |
| K851446 | UNIVERSAL SERVICE MODULE | Diasonics, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K851860 | DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM | Diasonics, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K853116 | PAXIAL | Biophysic Medical, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K852362 | UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52 | Johnson & Johnson Professionals, Inc. | 1985-10-31 | Traditional | PDF ↗ |
| K853087 | STORZ SOLID-STANDOFF PACHYMETRY PROBE | Storz Instrument Co. | 1985-10-16 | Traditional | PDF ↗ |
| K851895 | POLYGEL ULTRASOUND GEL | Parker Laboratories, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K851807 | RT2600(115V)(220/240V) #H4008A & H4008AE | General Electric Co. | 1985-09-19 | Traditional | PDF ↗ |
| K852570 | 5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517 | Siemens Medical Solutions USA, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K852571 | 3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509 | Siemens Medical Solutions USA, Inc. | 1985-09-19 | Traditional | PDF ↗ |
| K844686 | OPHTHASCAN B | Biophysic Medical, Inc. | 1985-09-13 | Traditional | PDF ↗ |
| K844184 | D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB | D.R.G. | 1985-09-06 | Traditional | PDF ↗ |
| K852549 | SONORANGER | Ausonics Pty , Ltd. | 1985-08-14 | Traditional | PDF ↗ |
| K851982 | KITECKO ULTRASOUND STANDOFF PAD | 3M Company | 1985-08-14 | Traditional | PDF ↗ |
| K851696 | AUSONICS 150 | Ausonics Pty , Ltd. | 1985-05-22 | Traditional | PDF ↗ |
| K844916 | MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER | Hoffrel Instruments, Inc. | 1985-04-22 | Traditional | PDF ↗ |
| K844299 | CORNEOMAP 4500 | Radionics Medical, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K843994 | AUSONICS 357 | Ausonics Pty , Ltd. | 1985-04-18 | Traditional | PDF ↗ |
| K850290 | ULTRASOUND GEL | Litton Datamedix | 1985-04-18 | Traditional | PDF ↗ |
| K843971 | AUSONICS 150 | Ausonics Pty , Ltd. | 1985-04-18 | Traditional | PDF ↗ |
| K850478 | PLUS 1 | Dymax Corp | 1985-04-15 | Traditional | PDF ↗ |
| K844393 | GL ULTRASOUND SECTOR 170 | Gl Ultrasound , Ltd. | 1985-04-10 | Traditional | PDF ↗ |
| K850580 | DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 | Elscint, Inc. | 1985-04-03 | Traditional | PDF ↗ |
| K850116 | BETASONIC III | Teknar, Inc. | 1985-03-29 | Traditional | PDF ↗ |
| K843696 | OPHTHALMIC A-SCAN A-2000 SONOME | Sonomed Technology, Inc. | 1985-02-26 | Traditional | PDF ↗ |
| K843205 | GL ULTRASOUND Z/SL 8300 | Gl Ultrasound , Ltd. | 1985-02-25 | Traditional | PDF ↗ |
| K844404 | IREX PS, PORTABLE SCANNER AND 118 | Irex Corp. | 1985-02-04 | Traditional | PDF ↗ |
| K844472 | CIVCO SCAN DRAPE | CIVCO Medical Instruments Co., Inc. | 1985-01-23 | Traditional | PDF ↗ |
| K844477 | STORZ CORNEO-SCAN II CS2000 | Storz Instrument Co. | 1985-01-23 | Traditional | PDF ↗ |
| K844449 | HIGH RESOLUTION 5 MHZ LINEAR ARRAY | Siemens Medical Solutions USA, Inc. | 1985-01-23 | Traditional | PDF ↗ |
| K842757 | ULTRASCAN DIGITAL B | CooperVision, Inc. | 1985-01-09 | Traditional | PDF ↗ |
| K843891 | DOPSCAN PLUS DS1060 | Carolina Medical Electronics | 1985-01-09 | Traditional | PDF ↗ |
| K843320 | RT-50 | General Electric Co. | 1984-12-27 | Traditional | PDF ↗ |
| K842900 | PHILIPS SDR 1200 | Philips Medical Systems, Inc. | 1984-12-13 | Traditional | PDF ↗ |
| K842880 | MECHANICAL SECTOR PROBE 4 MHZ DFM | General Electric Co. | 1984-12-10 | Traditional | PDF ↗ |
| K842777 | AUTOFOCUS DUAL ELEMENT PROBE | Technicare Corp. | 1984-11-29 | Traditional | PDF ↗ |
| K842376 | ULTRAMARK 4 ULTRASOUND SYS | Advanced Technology Laboratories, Inc. | 1984-10-05 | Traditional | PDF ↗ |
| K842093 | MK 700 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1984-09-27 | Traditional | PDF ↗ |
| K842897 | MEDICAL DIAG. ULTRASOUND INSTR. 77065 | Hewlett-Packard Co. | 1984-09-25 | Traditional | PDF ↗ |
| K843167 | SONIC AID GREEN ULTRASOUND GEL | Wpc Brands, Inc. | 1984-09-19 | Traditional | PDF ↗ |
| K842811 | ULTRASYSTEM LINSCAN PROBE | Kelley Development Corp. | 1984-09-17 | Traditional | PDF ↗ |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | American Medical Optics | 1984-09-07 | Traditional | PDF ↗ |
| K841817 | TECHNICARE 248 SL & 260SL | Technicare Corp. | 1984-08-17 | Traditional | PDF ↗ |
| K842591 | ULTRASOUND PROBE COVERS-STERILE | Applied Medical Devices, Inc. | 1984-07-23 | Traditional | PDF ↗ |
| K842153 | ULTRASOUND TRANSMISSION GEL | Wpc Brands, Inc. | 1984-07-18 | Traditional | PDF ↗ |
| K840540 | TECHNICARE MODEL 330 | Technicare Corp. | 1984-05-09 | Traditional | PDF ↗ |
| K840139 | IREX 720 SECTOR SCANNER | Irex Corp. | 1984-05-09 | Traditional | PDF ↗ |
| K833223 | SONEL 3000A | Cgr Medical Corp. | 1984-05-09 | Traditional | PDF ↗ |
| K841332 | CIVCO/SUPER SCAN | CIVCO Medical Instruments Co., Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K833667 | DIASONICS DLA-100 | Diasonics, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K840451 | BIOPSY ATTACHMENT;DYNEX ULTRASOUND- | Elscint, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K834284 | ULTRASOUND SCANNER 501 | Imex Medical Systems, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K840408 | LINEAR ARRAY TRANSDUCER OR SCANHEAD | Adr Ultrasound | 1984-04-25 | Traditional | PDF ↗ |
| K840138 | QTA PROCESSOR MODULE | General Electric Co. | 1984-04-25 | Traditional | PDF ↗ |
| K834280 | SDL-30 | Shimadzu Corp. | 1984-04-25 | Traditional | PDF ↗ |
| K834282 | ULTRA IMAGER 2000 | Honeywell, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K840667 | LINEAR SCANNER 640 | Ge Medical Systems Information Technologies | 1984-04-23 | Traditional | PDF ↗ |
| K834141 | ULTRASOUND SCAN HEAD 3.5 MHZ | Adr Ultrasound | 1984-04-20 | Traditional | PDF ↗ |
| K840611 | DSL-150 | Shimadzu Corp. | 1984-04-20 | Traditional | PDF ↗ |
| K834486 | TECHNICARE 280 | Technicare Corp. | 1984-04-13 | Traditional | PDF ↗ |
| K833225 | CALIBRE-TENTATIVE TRADENAME | Advanced Technology Laboratories, Inc. | 1984-02-28 | Traditional | PDF ↗ |
| K834087 | MODEL XLE | Interad Systems, Inc. | 1984-02-27 | Traditional | PDF ↗ |
| K834307 | ULTRASOUND SCANNER XL | Interad Systems, Inc. | 1984-02-21 | Traditional | PDF ↗ |
| K834277 | MOD 427 | Hoffrel Instruments, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K834285 | KC 100 M | Elscint, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K833680 | SIGMA 20 ELECTRONIC SECTOR SCANNER | Kontron Instruments, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K834276 | MOD 456 | Hoffrel Instruments, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K833231 | SOUND IMAGER I | Sound Imaging, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833222 | SINUSVU 2500 | Radionics Medical, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K833233 | HOT SHOT | Schiff Photo Mechanics | 1983-10-28 | Traditional | PDF ↗ |
| K832331 | US-1000 ULTRASONIC IMAGING SYSTEM | Nidek, Inc. | 1983-08-16 | Traditional | PDF ↗ |
| K820042 | OCULAR-BIOMETER 4000 | Radionics, Inc. | 1982-07-22 | Traditional | PDF ↗ |
| K813275 | EPCOM EMS SCAN II | Epcom Medical Systems, Inc. | 1982-03-31 | Traditional | PDF ↗ |
| K820365 | MARK 100 & 300 ULTRASOUND SYSTEM | Advanced Technology Laboratories, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K820364 | MARK 500 ULTRASOUOND SYSTEM | Advanced Technology Laboratories, Inc. | 1982-03-26 | Traditional | PDF ↗ |
| K813596 | AUTO SECTOR MCU | Technicare Corp. | 1982-03-25 | Traditional | PDF ↗ |
| K813177 | US ALOKA SSD-256 ULTRASONIC SCANNER | U. S. A. Imaging Corp. | 1982-03-05 | Traditional | PDF ↗ |
| K812686 | SINUSCOPE | Jedmed Instrument Co. | 1982-03-05 | Traditional | PDF ↗ |
| K820124 | INTEGRAL SECTOR MODULE | Siemens Gammasonics, Inc. | 1982-03-05 | Traditional | PDF ↗ |
| K813397 | SSD-240 ULTRASONIC SCANNER | U. S. A. Imaging Corp. | 1982-03-02 | Traditional | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.