Device, Spot-Film
Regulation 892.1670
0510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in IXL
| Company | 510(k)s | Recalls |
|---|---|---|
| Philips Medical Systems North America Co. Phillips | 0 | 3 |
| Applied X-Ray Technologies, Inc. | 2 | 0 |
| GE Medical Systems | 2 | 0 |
| Rms Div. | 2 | 0 |
| Continental X-Ray Corp. | 1 | 0 |
| Eastman Kodak Company | 1 | 0 |
| Fischer Imaging Corp. | 1 | 0 |
| General Electric Co. | 1 | 0 |
| Machlett Laboratories, Inc. | 1 | 0 |
| Philips Medical Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 19, 2011 | K111304 | OPTIMA XR120 Ge Medical Systems, LLC | IXL |
| Mar 4, 1997 | K964806 | MD-1835 Fischer Imaging Corp. | IXL |
| Feb 8, 1995 | K950317 | ADVANTX 1824 SPOTFILM DEVICE GE Medical Systems | IXL |
| Aug 17, 1994 | K940386 | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP Eastman Kodak Company | IXL |
| Jun 6, 1994 | K942367 | AXT 1400 SPOTFILM DEVICE Applied X-Ray Technologies, Inc. | IXL |
| Nov 24, 1992 | K924593 | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 Philips Medical Systems, Inc., NL | IXL |
| Aug 1, 1990 | K902403 | ELITE R/F SPOT FILM DRIVE Rms Div. | IXL |
| May 31, 1990 | K902146 | SFD-035 SPOT FILM DEVICE Rms Div. | IXL |
| Jul 21, 1988 | K882492 | A.X.T. SPOTFILM DEVICE Applied X-Ray Technologies, Inc. | IXL |
| Jul 18, 1988 | K881589 | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 Continental X-Ray Corp. | IXL |
| Jul 17, 1984 | K842184 | SPOT-FILM DEVICE 8835 General Electric Co. | IXL |
| Jan 9, 1981 | K802888 | RAYTHEON MEDICAL IMAGING Machlett Laboratories, Inc. | IXL |
| Apr 10, 1980 | K800554 | MULTI-FORMAT SFD MODEL 1720 Philips Medical Systems (Cleveland), Inc. | IXL |
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