FDA Product Code
FDA Product Code IZH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1710
510(k) Clearances — 176 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934748 | LORAD M-IIE MODIFICATION | Lorad Corp. | 1994-01-31 | Traditional | PDF ↗ |
| K934625 | LORAD M-III | Lorad Corp. | 1994-01-28 | Traditional | PDF ↗ |
| K933754 | CHENOWETH-FRANK RADIOPATHOLOGICAL GRID | Cook, Inc. | 1993-09-20 | Traditional | PDF ↗ |
| K930282 | AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS | Elscint, Inc. | 1993-08-23 | Traditional | PDF ↗ |
| K925725 | CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR | Bennett X-Ray Corp. | 1993-02-26 | Traditional | PDF ↗ |
| K925212 | GIOTTO PATIENT BED | Gold Coast Imaging, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K923471 | PLANMED CYTOGUIDE | Planmed OY | 1992-11-24 | Traditional | PDF ↗ |
| K921962 | LORAD DIGITAL SPOT MAMMOGRAPHY | Lorad Medical Systems, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K921986 | PATIENT INFORMATION MANAGER (PIM) | Continental X-Ray Corp. | 1992-10-16 | Traditional | PDF ↗ |
| K922454 | MOBILE ATHENA HF | Fischer Imaging Corp. | 1992-09-11 | Traditional | PDF ↗ |
| K923061 | MAMMOSCAN | Fischer Imaging Corp. | 1992-09-10 | Traditional | PDF ↗ |
| K920470 | MEYER FOREIGN BODY LOCATOR | Seymour W. Meyer | 1992-08-26 | Traditional | PDF ↗ |
| K921896 | TILTING MAG | Continental X-Ray Corp. | 1992-08-03 | Traditional | PDF ↗ |
| K915201 | CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO | Bennett X-Ray Corp. | 1992-07-28 | Traditional | PDF ↗ |
| K922619 | DIGITIZER, MODEL # 3-000A-1518 | Lorad Medical Systems, Inc. | 1992-07-01 | Traditional | PDF ↗ |
| K920938 | VJW2919 PNEUMATIC COMPRESSION UPGRADE | Varian Canada, Inc. | 1992-06-17 | Traditional | PDF ↗ |
| K915748 | AVIVA MAMMOGRAPHIC X-RAY SYSTEM | Elscint, Inc. | 1992-02-04 | Traditional | PDF ↗ |
| K913732 | MAMMOGRAPHIC X-RAY SYSTEM | Lorad Medical Systems, Inc. | 1992-02-03 | Traditional | PDF ↗ |
| K913418 | SENOGRAPHE DMR/SMR/DM | General Electric Co. | 1992-01-06 | Traditional | PDF ↗ |
| K913845 | PHILIPS MAMMODIAGNOST BC | Philips Medical Systems, Inc. | 1991-12-20 | Traditional | PDF ↗ |
| K914328 | MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM | Siemens Medical Solutions USA, Inc. | 1991-12-02 | Traditional | PDF ↗ |
| K910111 | VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS | Instrumentarium Imaging, Inc. | 1991-09-23 | Traditional | PDF ↗ |
| K912974 | MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM | Elscint, Inc. | 1991-09-19 | Traditional | PDF ↗ |
| K896596 | ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL | Instrumentarium Imaging, Inc. | 1991-05-30 | Traditional | PDF ↗ |
| K904953 | PLANMED SOPHIE | Planmeca USA, Inc. | 1991-04-18 | Traditional | PDF ↗ |
| K905748 | MAMEX DC AMI SL12/MG15 | Soredex, Inc. | 1991-03-07 | Traditional | PDF ↗ |
| K903651 | AMI MAMMOSPOT | American Mammographics, Inc. | 1990-11-15 | Traditional | PDF ↗ |
| K904517 | MAMMOSPOT 3 AND MAMMOSPOT 8 | American Mammographics, Inc. | 1990-11-15 | Traditional | PDF ↗ |
| K901558 | GIOTTO MAMMOGRAPHY HF | Medical Device Marketing Network, Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K901997 | X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS | Comet Ltd. C/O Radiology Resources, Inc. | 1990-06-06 | Traditional | PDF ↗ |
| K900989 | ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM | Fischer Imaging Corp. | 1990-03-28 | Traditional | PDF ↗ |
| K896609 | CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC | Philips Medical Systems North America, Inc. | 1990-01-31 | Traditional | PDF ↗ |
| K892342 | TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM | Bay Shore Medical Equipment Corp. | 1989-11-17 | Traditional | PDF ↗ |
| K884107 | STEREOTACTIC BIOPSY ATTACHMENT | Siemens Medical Solutions USA, Inc. | 1989-05-05 | Traditional | PDF ↗ |
| K890784 | MAMMOMAT C | Siemens Medical Solutions USA, Inc. | 1989-05-03 | Traditional | PDF ↗ |
| K885020 | CYTOGUIDE | Philips Medical Systems North America, Inc. | 1989-04-26 | Traditional | PDF ↗ |
| K891090 | SPECBOARD | Macbrud Corp. Medical Div. | 1989-04-07 | Traditional | PDF ↗ |
| K884345 | MODEL ESP-200 MAMMOGRAPHIC SYSTEM | Acoma Medical Imaging, Inc. | 1989-03-23 | Traditional | PDF ↗ |
| K890483 | THE PATHFINDER SYSTEM | Denmark Assoc. | 1989-03-14 | Traditional | PDF ↗ |
| K884917 | RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM | Amg Medical Equipments, Inc. | 1989-03-09 | Traditional | PDF ↗ |
| K885135 | MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150 | Bennett X-Ray Corp. | 1989-03-09 | Traditional | PDF ↗ |
| K884676 | MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. | Elscint, Inc. | 1989-01-06 | Traditional | PDF ↗ |
| K884677 | MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI. | Elscint, Inc. | 1989-01-06 | Traditional | PDF ↗ |
| K882875 | STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY | Lorad Medical Systems, Inc. | 1988-11-07 | Traditional | PDF ↗ |
| K882133 | MAMMO M | Ziehm International, Inc. | 1988-09-19 | Traditional | PDF ↗ |
| K881697 | BREAST LESION LOCALIZATION NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-09-14 | Traditional | PDF ↗ |
| K881505 | MAMEX DC MG11 | Orion Corp. | 1988-06-10 | Traditional | PDF ↗ |
| K881506 | MAMEX DC MAG MG12 | Orion Corp. | 1988-06-10 | Traditional | PDF ↗ |
| K881882 | SENOGRAPHE 600T AND 600TS SENIX HF | General Electric Co. | 1988-05-25 | Traditional | PDF ↗ |
| K880531 | MAMMOGRAPHIC X-RAY SYSTEM ATHENA | Fischer Imaging Corp. | 1988-05-02 | Traditional | PDF ↗ |
| K880905 | MAMMOGRAPHY MOVING GRID BUCKY | Custom Medical Products, Ltd. | 1988-03-21 | Traditional | PDF ↗ |
| K875377 | SHIMADZU MAMMOGRAPHIC STAND MR-30 | Shimadzu Precision Instruments, Inc. | 1988-02-12 | Traditional | PDF ↗ |
| K874040 | MAMEX DC S SL10/MG14 | Orion Corp. | 1987-11-23 | Traditional | PDF ↗ |
| K873618 | STEREOTIX | Thomson-Cgr Medical Corp. | 1987-11-16 | Traditional | PDF ↗ |
| K873836 | MAMMOGRAPHIC KVP METER MODEL 232 | Radiation Measurements, Inc. | 1987-10-16 | Traditional | PDF ↗ |
| K872734 | MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE | Palomex Instrumentarium Corp. | 1987-10-08 | Traditional | PDF ↗ |
| K871048 | MICRO MAMMO I MAMMOGRAPHY UNIT | Amerasia Import-Export, Inc. | 1987-09-01 | Traditional | PDF ↗ |
| K872980 | MAM-CP X-RAY APPARATUS | Transworld X-Ray Corp. | 1987-08-27 | Traditional | PDF ↗ |
| K871592 | RF-1 CIRCUIT | Diagnostic Imaging Specialists Corp. | 1987-05-22 | Traditional | PDF ↗ |
| K864958 | ALPHA II DIAGNOSTIC X-RAY | Ausonics Pty , Ltd. | 1987-01-30 | Traditional | PDF ↗ |
| K861692 | FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM | Fischer Imaging Corp. | 1986-12-15 | Traditional | PDF ↗ |
| K863710 | ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT | Ausonics Pty , Ltd. | 1986-10-14 | Traditional | PDF ↗ |
| K860129 | ISO-MAMMO | Philips Medical Systems (Cleveland), Inc. | 1986-03-06 | Traditional | PDF ↗ |
| K854203 | TEC 2720 MAMEX DC MAG | Tecnomed, Inc. | 1986-03-06 | Traditional | PDF ↗ |
| K854510 | MINXRAY 500M MAMMOGRAPHIC SYSTEM | Minxray, Inc. | 1986-01-01 | Traditional | PDF ↗ |
| K853395 | RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000 | Raytheon Medical Systems | 1985-11-01 | Traditional | PDF ↗ |
| K844119 | MAMMOGRAPH III | American Medical Imports, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K850173 | AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT | Ausonics Pty , Ltd. | 1985-04-16 | Traditional | PDF ↗ |
| K850614 | SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY | S & S X-Ray Products, Inc. | 1985-03-26 | Traditional | PDF ↗ |
| K843437 | MEI MAMMOGRAPHY SYS MX-2049 | Moti Enterprises, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K842102 | LORAD | Lorad Medical Systems, Inc. | 1984-07-17 | Traditional | PDF ↗ |
| K841774 | UNIMACS, PATENT PENDING UNIVERSAL MAM | Technical Devices For Medicine | 1984-06-26 | Traditional | PDF ↗ |
| K833243 | MAMMOGRAPHIC S-RAY SYSTEM | Xerox Medical Systems | 1983-10-28 | Traditional | PDF ↗ |
| K832733 | XEROX 120 SYS MAMMOGRAPHIC X-RAY | Xerox Medical Systems | 1983-09-29 | Traditional | PDF ↗ |
| K790273 | MAMMOGRAPHY SYSTEM AND CASSETTE | Agfa-Gevaert, Inc. | 1979-03-21 | Traditional | PDF ↗ |
| K770693 | X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC | Xonics Medical Systems, Inc. | 1977-08-03 | Traditional | PDF ↗ |
Product code IZH · Class II · Radiology. Data: openFDA.