Tube Mount, X-Ray, Diagnostic
Regulation 892.1770
0510(k)s in 12 months (40 all time)
1recalls in 12 months (13 all time)
5recalls that name a 510(k)
Top companies in IYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Fischer Imaging Corp. | 5 | 2 |
| Shimadzu Medical Systems | 4 | 0 |
| Siemens Medical Solutions USA, Inc | 0 | 4 |
| Bennett X-Ray Corp. | 3 | 0 |
| Del Medical Systems Group | 0 | 3 |
| Radkor, Inc. | 3 | 0 |
| Acoma Medical Imaging, Inc. | 2 | 0 |
| General Electric Co. | 2 | 0 |
| Medicor USA , Ltd. | 2 | 0 |
| SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | 0 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 1996 | K935123 | SUPERSTAND 300 Wuestec Medical, Inc. | IYB |
| Feb 15, 1995 | K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, SUPER EURO 4072, 5000 Scott Imaging Intl., Inc. | IYB |
| Jul 29, 1994 | K941017 | F/C/W TUBESTAND Acoma Medical Imaging, Inc. | IYB |
| Jul 29, 1994 | K941004 | CTS SYSTEM Acoma Medical Imaging, Inc. | IYB |
| Jun 9, 1994 | K940442 | MPR-814 Xri, Inc. | IYB |
| Dec 13, 1993 | K935004 | MODEL ALPHA TS-2 Dpa Consulting, Inc. | IYB |
| Aug 16, 1993 | K933253 | SUPERSTAND 3000 Wuestec Medical, Inc. | IYB |
| Dec 17, 1992 | K925716 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC Bennett X-Ray Corp. | IYB |
| Dec 7, 1992 | K925170 | SHIMADZU X-RAY TUBE STAND BH-100 SERIES Shimadzu Medical Systems | IYB |
| Apr 16, 1992 | K920727 | CEILING TUBE SUPPORT CH-30X Shimadzu Medical Systems | IYB |
| Dec 2, 1991 | K914944 | BENNETT OVERHEAD TUBE CRANE MODEL NO. B-OTC Bennett X-Ray Corp. | IYB |
| Nov 1, 1991 | K914348 | ER-1000 CATHERIZATION C-ARM SYSTEMS Shimadzu Medical Systems | IYB |
| Oct 23, 1991 | K911563 | INVENTOR RT/EXPLORER TRAUMA UNIT Continental X-Ray Corp. | IYB |
| Sep 16, 1991 | K912696 | TRAUMA VIEW RAD SYST MODEL #B-TRV/STRET MOBIL TABL Bennett X-Ray Corp. | IYB |
| Feb 26, 1990 | K900234 | PFM-90 CEILING TUBE SUPPORT Fischer Imaging Corp. | IYB |
| Sep 22, 1989 | K895188 | SHIMADZU X-RAY TUBE STAND FH-31 Shimadzu Medical Systems | IYB |
| Jun 23, 1989 | K893653 | RADIOGRAPHIC CEILING TUBE SUPPORT CTS15 Fischer Imaging Corp. | IYB |
| Jun 23, 1989 | K893652 | RADIOGRAPHIC FLOOR MOUNTED TUBESTAND FM 60 Fischer Imaging Corp. | IYB |
| Nov 7, 1988 | K883664 | LUM VASCULAR PROCEDURE SYSTEM #B5200A General Electric Co. | IYB |
| Oct 19, 1988 | K883864 | RADKOR SFR-70 Radkor, Inc. | IYB |
| Sep 8, 1988 | K881701 | RADKOR SFC-21 Radkor, Inc. | IYB |
| Jul 8, 1988 | K882563 | RADKOR, CST-18 Radkor, Inc. | IYB |
| Mar 3, 1988 | K880530 | CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX Fischer Imaging Corp. | IYB |
| Feb 29, 1988 | K880528 | OVERHEAD TUBE MOUNT CASCADE II Fischer Imaging Corp. | IYB |
| Sep 10, 1987 | K873283 | MODEL C2-5000 OVERHEAD TUBE SUPPORT Transworld X-Ray Corp. | IYB |
| Mar 30, 1987 | K870856 | COSMOS Pausch Corp. | IYB |
| Aug 1, 1986 | K862827 | FCW TUBE STAND Garrels X-Ray Products, Inc. | IYB |
| Aug 1, 1986 | K862734 | CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND D&R X-Ray Products, Inc. | IYB |
| Jun 19, 1986 | K861995 | MODEL RS-3 RADIOGRAPHIC STAND Medicor USA , Ltd. | IYB |
| Sep 26, 1985 | K852952 | TRAUMA STAND Xre Corp. | IYB |
| Sep 19, 1985 | K853682 | MOUNT TUBE RADIOGRAPHIC X-Ray Systems | IYB |
| May 14, 1985 | K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG Summit Industries, Inc. | IYB |
| Feb 21, 1985 | K844337 | X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY Quality X-Ray Manufacturing, Inc. | IYB |
| Dec 17, 1984 | K843928 | COUNTERBALANCED VERTICAL CASSETTE HOLDER Poersch Metal Mfg. Co. | IYB |
| Nov 27, 1984 | K843335 | FLOOR MOUNTED X-RAY TUBESTAND Medicor USA , Ltd. | IYB |
| Aug 13, 1981 | K811970 | AP X-RAY TUBE ANGULATION DEVICE Philips Medical Systems (Cleveland), Inc. | IYB |
| Jun 9, 1981 | K811195 | ARGOSTAT Tecnomed, Inc. | IYB |
| Jan 28, 1981 | K803162 | X-RAY STAND & OPERATING CHAIR Downs Surgical , Ltd. | IYB |
| Nov 27, 1978 | K781571 | L/U ARM-VASCULAR General Electric Co. | IYB |
| Jul 17, 1978 | K781065 | PLURIMAT;RADIOGRAPHIC TUBE MOUNT Tecnomed, Inc. | IYB |
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