Device, Beam Limiting, X-Ray, Diagnostic
Regulation 892.1610
0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KPW
| Company | 510(k)s | Recalls |
|---|---|---|
| Ralco S.R.L. | 2 | 0 |
| Tecnomed, Inc. | 2 | 0 |
| Arrow X-Ray Corp. | 1 | 0 |
| Dial-X Instruments, Inc. | 1 | 0 |
| Eureka X-Ray Tube Corp. | 1 | 0 |
| L. Keroack Co. | 1 | 0 |
| Litton Medical Systems | 1 | 0 |
| Lumos, Inc. | 1 | 0 |
| Precise Optics | 1 | 0 |
| Siemens Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 12, 2010 | K093596 | LUMOS, MODEL R 72B Lumos, Inc. | KPW |
| Dec 28, 2006 | K062788 | COLLIMATOR, MODEL M-38 Umi International | KPW |
| Aug 1, 2003 | K030487 | R 72 Ralco S.R.L. | KPW |
| Oct 18, 1995 | K954310 | BLA-800A Toshiba Medical Systems | KPW |
| May 11, 1995 | K946320 | R 302 Ralco S.R.L., IT | KPW |
| Nov 27, 1991 | K914184 | P2020-8-0 BEAM-LIMITING DEVICE Precise Optics | KPW |
| Jan 24, 1991 | K904587 | DENSICOMP 250 L. Keroack Co., CA | KPW |
| Nov 29, 1990 | K904044 | TF-63SA Toshiba America Medical Systems, In.C | KPW |
| Oct 15, 1990 | K904489 | EUREKA EXTENSION CYLINDERS Eureka X-Ray Tube Corp. | KPW |
| Mar 5, 1982 | K820306 | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC Tecnomed, Inc. | KPW |
| Mar 4, 1982 | K820305 | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC Tecnomed, Inc. | KPW |
| Feb 18, 1982 | K820119 | PODIOSCOPE BY ARROW Arrow X-Ray Corp. | KPW |
| Jul 2, 1981 | K811450 | ALUMINUM FILTRATION SYSTEM Wedge Filtration System | KPW |
| Sep 7, 1979 | K791504 | AUTOMATIC POSITIVE BEAM COLLIMATOR Dial-X Instruments, Inc. | KPW |
| Dec 4, 1978 | K781984 | COLLIMATOR, HEART CONTOUR Siemens Corp. | KPW |
| Feb 28, 1977 | K770335 | COLLIMATOR, AUTOMATIC Litton Medical Systems | KPW |
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