System, X-Ray, Mammographic
Regulation 892.1710
0510(k)s in 12 months (176 all time)
0recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in IZH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 5, 1999 | K984092 | PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 Trex Medical Corp. | IZH |
| Feb 5, 1999 | K984091 | CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 Trex Medical Corp. | IZH |
| Dec 11, 1998 | K983313 | ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY Elscint, Inc. | IZH |
| Nov 16, 1998 | K983659 | PLANMED SOPHIE & PLANNED SOPHIE CLASSIC Planmed OY, FI | IZH |
| Nov 3, 1998 | K983621 | NEEDLE GUIDE Remington Medical, Inc. | IZH |
| Jul 17, 1998 | K981641 | MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ Instrumentarium Corp. | IZH |
| Jul 14, 1998 | K982049 | BIOPSY M Sitco, Inc. | IZH |
| Jun 19, 1998 | K981470 | WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE Worldwide Medical Technologies, LLC | IZH |
| Apr 9, 1998 | K980235 | REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) Kci New Technologies, Inc. | IZH |
| Dec 23, 1997 | K973631 | LORAD M-III ELITE (M-III E) Lorad Corp. | IZH |
| Nov 21, 1997 | K973856 | GIOTTO HT Sitco, Inc. | IZH |
| Nov 10, 1997 | K973915 | INFLATABLE POSITIONING CUSHIONS Kci New Technologies, Inc. | IZH |
| Nov 10, 1997 | K973493 | PLANMED CYTOGUIDE Planmed OY | IZH |
| Nov 10, 1997 | K973400 | MAMMOTEST ADAPTER DRIVER Fischer Imaging Corp. | IZH |
| Jun 20, 1997 | K970680 | GLORY Elscint, Inc. | IZH |
| May 8, 1997 | K964069 | DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM Siemens Medical Solutions USA, Inc. | IZH |
| Mar 19, 1997 | K953902 | GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM Medical Marketing Intl., Inc. | IZH |
| Feb 5, 1997 | K962105 | PLANNED SOPHIED CLASSIC Planmed OY, FI | IZH |
| Jan 10, 1997 | K964576 | PROFILE MAMMOGRAPHY SYSTEM (M-PRO) Bennett X-Ray Corp. | IZH |
| Aug 21, 1996 | K961849 | THE ROBOGUIDE Shai Syg Motion and Innovations, Ltd., IL | IZH |
| Apr 29, 1996 | K960381 | MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION Elscint, Inc. | IZH |
| Mar 21, 1996 | K955411 | DELTA 16 Instrumentarium Imaging, Inc., FI | IZH |
| Jan 26, 1996 | K953250 | SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE GE Medical Systems | IZH |
| Dec 22, 1995 | K955249 | SENSOR PAD Inventive Products, Inc. | IZH |
| Oct 24, 1995 | K954521 | MAMMOSPOT PADDLE American Mammographics, Inc. | IZH |
| Jul 24, 1995 | K952210 | LORAD STEROLOC II Lorad Corp. | IZH |
| May 24, 1995 | K951883 | PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT Planmed OY, FI | IZH |
| May 11, 1995 | K941191 | REAL TIME STEREOTIX GE Medical Systems | IZH |
| May 3, 1995 | K944978 | BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI Bennett X-Ray Corp. | IZH |
| Apr 3, 1995 | K945962 | BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY Bennett X-Ray Corp. | IZH |
| Mar 31, 1995 | K945743 | PREFERENCE MAMMOGRAPHY SYSTEM Philips Medical Systems (Cleveland), Inc. | IZH |
| Mar 31, 1995 | K945241 | LORAD M-IV, LORAD M-IVI Lorad Corp. | IZH |
| Mar 31, 1995 | K941353 | MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM Elscint, Inc. | IZH |
| Mar 23, 1995 | K945619 | ATHENA HFX Fischer Imaging Corp. | IZH |
| Mar 2, 1995 | K950608 | DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION Lorad Corp. | IZH |
| Feb 8, 1995 | K944816 | SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) Philips Medical Systems (Cleveland), Inc. | IZH |
| Feb 8, 1995 | K932356 | NOVA XM2 Dynarad Corp. | IZH |
| Jan 31, 1995 | K934478 | ALPHA STEREO Instrumentarium Corp., FI | IZH |
| Dec 27, 1994 | K945496 | MAMMOGRAPHIC X-RAY UNIT Lorad Corp. | IZH |
| Dec 14, 1994 | K945272 | RHODIUM FILTER Lorad Corp. | IZH |
| Nov 1, 1994 | K935428 | BENNETT X-RAY DIGITAL SPOT IMAGER Bennett X-Ray Technologies | IZH |
| Oct 14, 1994 | K934868 | LORAD TRANSPO Lorad Corp. | IZH |
| Sep 22, 1994 | K933430 | CYTOGUIDE STEREOTATIC BIOPSY SYSTEM Gold Coast Imaging, Inc. | IZH |
| Sep 14, 1994 | K932672 | MAMMOMAT 300 AND MAMMOMAT 3000 Siemens Medical Solutions USA, Inc. | IZH |
| Aug 23, 1994 | K934831 | ADVANCED AUTOMATIC KV Elscint, Inc. | IZH |
| May 17, 1994 | K935608 | MAMOSPAT E.V.S. Tool & Die Co., Inc. | IZH |
| May 4, 1994 | K936161 | SYSTEM, X-RAY, MAMOGRAPHIC Technowipe | IZH |
| Apr 28, 1994 | K940701 | BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH Bennett X-Ray Corp. | IZH |
| Apr 7, 1994 | K934373 | MOBILE SOPHIE MODIFICATION Planmed OY, FI | IZH |
| Jan 31, 1994 | K934870 | LORAD D-550 Lorad Corp. | IZH |
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