Monitor, Patient Position, Light-Beam
Regulation 892.5780
0510(k)s in 12 months (28 all time)
1recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in IWE
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtec, Inc. | 7 | 0 |
| Diacor, Inc. | 4 | 0 |
| A2j, Inc. | 3 | 0 |
| Cp Bio-Medical Corp. | 3 | 0 |
| GE Healthcare | 0 | 3 |
| Omega Medical Imaging, Inc. | 0 | 3 |
| Medical Alignment Systems | 2 | 0 |
| Advantage Medical Systems, Inc. | 1 | 0 |
| Atc Medical Technology, Inc. | 1 | 0 |
| Gammex, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2015 | K152303 | CT Sim Laser System Gammex, Inc. | IWE |
| Nov 20, 1997 | K973162 | DUAL RADIATION TARGETING SYSTEM DRTS DRAPE Hogan & Hartson | IWE |
| May 24, 1996 | K955236 | GREEN TEC-2100 Medtec, Inc. | IWE |
| Oct 23, 1995 | K954414 | CENTRALITE BACKPOINTER Diacor, Inc. | IWE |
| Aug 18, 1995 | K950293 | TEC-2110 GREEN LASER MODEL MT-HNG Medtec, Inc. | IWE |
| Aug 16, 1995 | K950112 | CENTRALITE(R)-DLL SERIES Diacor, Inc. | IWE |
| May 11, 1995 | K951601 | MED-TEC STRING RETICLE TRAY Medtec, Inc. | IWE |
| Dec 7, 1994 | K943802 | HP BACK POINTER SYSTEM Medtec, Inc. | IWE |
| Aug 9, 1994 | K943381 | LASER ALIGNMENT TOOL Philips Medical Systems North America, Inc. | IWE |
| Jul 18, 1994 | K941169 | TEC 2101 (MODEL MT-HPLGD) Medtec, Inc. | IWE |
| Jan 25, 1994 | K935760 | TEC 2100 (MODEL MT-LPLGD) Medtec, Inc. | IWE |
| Dec 13, 1993 | K934519 | RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM Medtec, Inc. | IWE |
| Oct 8, 1993 | K931974 | AZ 92 A2j, Inc. | IWE |
| Jun 4, 1993 | K930294 | PATPOS GREEN Cp Bio-Medical Corp. | IWE |
| May 21, 1993 | K930296 | PATPOS RED Cp Bio-Medical Corp. | IWE |
| May 21, 1993 | K930295 | PATPOS COMPACT Cp Bio-Medical Corp. | IWE |
| Nov 16, 1992 | K923619 | ACCULITE SSL Medical Alignment Systems | IWE |
| Jan 4, 1991 | K904127 | A2J TELEMETER A2j, Inc. | IWE |
| Nov 9, 1990 | K904753 | DIOLASE Scanditronix, Inc., SE | IWE |
| Aug 17, 1989 | K893398 | CENTRALITE BACKPOINTER Diacor, Inc. | IWE |
| Apr 22, 1988 | K880981 | A2J MZ 44 B TYPE A2j, Inc. | IWE |
| Aug 12, 1987 | K872894 | A2J MZ 44 LASER LIGHT FOR POSITIONING Prometex, Inc. | IWE |
| Aug 12, 1987 | K872841 | ACCULITE Medical Alignment Systems | IWE |
| Jul 15, 1987 | K872489 | CENTRALITE Diacor, Inc. | IWE |
| Jul 3, 1986 | K860472 | NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS Nuclear Diagnostics, Inc. | IWE |
| Aug 20, 1980 | K801541 | WALL MOUNTED LASER POSITIONING DEVICE Advantage Medical Systems, Inc. | IWE |
| Mar 25, 1980 | K800489 | LASER BACKPOINTER ASSEMBLY, MOD. 01-2487 Atc Medical Technology, Inc. | IWE |
| Mar 3, 1980 | K800223 | PATIENT POSITIONING SYSTEM 1D OR 2D Laboratoire National D'Essais | IWE |
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