Interventional Fluoroscopic X-Ray System
Regulation 892.1650
18510(k)s in 12 months (325 all time)
110recalls in 12 months (638 all time)
607recalls that name a 510(k)
Top companies in OWB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2001 | K011311 | UROLOGIC Pck Electronic Industry and Trade Co, Ltd., TR | OWB |
| Jun 20, 2001 | K011292 | ZIEHM VISION Ziehm International, Inc. | OWB |
| Apr 12, 2001 | K010942 | U04 Siemens Medical Solutions USA, Inc. | OWB |
| Mar 12, 2001 | K010435 | PHILIPS BV PULSERA/ENDURA Philips Medical Systems, Inc., NL | OWB |
| Oct 17, 2000 | K002198 | FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS Fluoro Scan Imaging Systems, Inc. | OWB |
| Sep 6, 2000 | K002016 | PHILIPS INTEGRIS ALLURA Philips Medical Systems North America, Inc., NL | OWB |
| Apr 11, 2000 | K000221 | SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM Ge Dec Medical Systems | OWB |
| Feb 14, 2000 | K993037 | LCV+ VERSION 2 Ge Medical Systems, Inc. | OWB |
| Dec 21, 1999 | K993687 | UROVIEW 2800 Ge Dec Medical Systems | OWB |
| Nov 5, 1999 | K992660 | URF DIGITAL - OT Siemens Medical Solutions USA, Inc. | OWB |
| Sep 1, 1999 | K992103 | C-QUEST Wuestec Medical, Inc. | OWB |
| Nov 2, 1998 | K983069 | PHILIPS DUO DIAGNOST Philips Medical Systems North America, Inc. | OWB |
| Sep 29, 1998 | K982993 | PHILIPS OMNIDIAGNOST Philips Medical Systems, Inc., NL | OWB |
| Sep 23, 1998 | K982427 | TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C Trex Medical Corp. | OWB |
| Feb 17, 1998 | K974355 | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) Ge Dec Medical Systems | OWB |
| Apr 21, 1997 | K970734 | SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS Siemens Medical Solutions USA, Inc. | OWB |
| Mar 11, 1997 | K970063 | SERIES 7600 MOBILE DIGITAL C-ARM Ge Dec Medical Systems | OWB |
| Dec 23, 1996 | K963952 | SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM Ge Dec Medical Systems | OWB |
| Sep 5, 1996 | K961105 | SKIN DOSE MONITOR Mcmahon Medical | OWB |
| Aug 19, 1996 | K961374 | PHILIPS MULTIDIAGNOST 4 Philips Medical Systems, Inc., NL | OWB |
| May 20, 1996 | K960920 | CLINIX MP Philips Medical Systems (Cleveland), Inc. | OWB |
| Apr 29, 1994 | K921219 | PHILIPS DCI-SX Philips Medical Systems, Inc., NL | OWB |
| Mar 16, 1994 | K936180 | TC+ SYSTEM (TILTING C-ARM SYSTEM) GE Medical Systems | OWB |
| Sep 15, 1992 | K923049 | UROSKOP D1, UROSKOP D2, AND UROSKOP D3 Siemens Medical Solutions USA, Inc. | OWB |
| Aug 28, 1991 | K912448 | CSP Fischer Imaging Corp. | OWB |
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