Drx-Evolution, Model VX3733-Sys

• 2 recalls, same reason

  • Terminated Z-0797-2014 FDA Class II ·initiated 25 Nov 2013 ·on shared 510(k) K091889
  • Terminated Z-0796-2014 FDA Class II ·initiated 25 Nov 2013 ·on shared 510(k) K091889

  Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.

• • Terminated Z-1877-2013 FDA Class II ·initiated 3 Jun 2013

  Due to potential for an x-ray exposure technique change.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 20 Jul 2009 Cleared FDA 510(k) K091889
2. 3 Jun 2013 Recall initiated FDA recalls Z-1877-2013
3. 25 Nov 2013 Recall initiated FDA recalls Z-0797-2014
4. 25 Nov 2013 Recall initiated FDA recalls Z-0796-2014

510(k) Number

K091889 ↗

FDA product code

KPR

Device class

Class II

Regulation

21 CFR Part 892.1680

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code KPR (System, X-Ray, Stationary).

• FUJI COMPUTED RADIOGRAPHY OD-F623 OPTICAL-DISK by Fujifilm Medical System U.S.A., Inc.
• Diamentor Patient X-Ray Exposure Indicator 07302 by Victoreen, Inc.
• Armboard by Mtd, Inc.
• Imasight 4600 Digital Radiography Sensor by Imasight, Inc.
• OTC DDR System by Konica Minolta Healthcare Americas, Inc
• Flaatz 760 by Drtech Corp.
• Z-Motion Digital Diagnostic X-Ray System by Control-X Medical, Inc.
• DR-ID 900MC DR-ID 900 MC E by FUJIFILM CORPORATION
• AeroDR System with P-21 by Konica Minolta Medical & Graphic, Inc.
• Ysio Max by Siemens Medi Cal Solutions, Inc.

• Lux HD 43

  Class IIa

  CE/MDR

• Lux HD 2530

  Class IIa

  CE/MDR

• Lux HD 35 Detector

  Class IIa

  CE/MDR

• Q-RAD System

  Class II

  FDA 510(k) K011486 Active Cleared 20 Jun 2001 GUDID on market

See all devices from Carestream Health, Inc. →