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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Show TPLC since Back To Search Results
Device system, x-ray, stationary
Regulation Description Stationary x-ray system.
Product CodeKPR
Regulation Number 892.1680
Device Class 2


Premarket Reviews
ManufacturerDecision
ACROMA AB
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
CMT MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
CUATTRO, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEL MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
EOS IMAGING
  SUBSTANTIALLY EQUIVALENT 2
GE HUALUN MEDICAL SYSTEMS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
GEMSS MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HALIFAX BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JPI HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KONICA MINOLTA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICATECH USA
  SUBSTANTIALLY EQUIVALENT 2
ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSKO, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ROESYS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 13
SAMSUNG ELECTRONICS CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 3
SG HEALTHCARE CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS CAPITAL
  SUBSTANTIALLY EQUIVALENT 4
SOURCE-RAY, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Use of Device Problem 23
Device Operational Issue 14
Improper or Incorrect Procedure or Method 10
Unintended Movement 8
Component Falling 5
Unintended System Motion 4
Adverse Event Without Identified Device or Use Problem 3
Appropriate Term/Code Not Available 3
Failure To Adhere Or Bond 2
Fire 2
Device Component Or Accessory 2
Mechanical Problem 2
Insufficient Information 2
Detachment Of Device Component 2
Unintended Collision 2
Off-Label Use 2
Installation-Related Problem 2
Device Handling Problem 2
Device Issue 1
Incorrect Device Or Component Shipped 1
Break 1
Detachment of Device or device Component 1
Packaging Problem 1
Wiring Harness 1
Cable 1
Device Operates Differently Than Expected 1
Human-Device Interface Problem 1
Defective Component 1
Data Problem 1
Screw 1
Structural Problem 1
Device Dislodged or Dislocated 1
Electrical /Electronic Property Problem 1
Total Device Problems 105

Recalls
Manufacturer Recall Class Date Posted
1 AGFA Healthcare Corp. II Aug-10-2014
2 AGFA Healthcare Corp. II Apr-05-2017
3 Agfa N.V. II Sep-25-2018
4 Agfa-Gevaert, N.V. II Jan-07-2019
5 Carestream Health Inc II Aug-22-2015
6 Carestream Health Inc. II Aug-01-2014
7 Carestream Health Inc. II Jan-29-2014
8 Carestream Health, Inc. II Aug-10-2014
9 Carestream Health, Inc. II Jan-27-2014
10 Fujifilm Medical Systems U.S.A., Inc. II Dec-10-2017
11 GE Healthcare II Mar-06-2015
12 GE Healthcare II Jan-12-2015
13 GE Healthcare, LLC II Jun-10-2019
14 GE Healthcare, LLC II Jul-16-2018
15 GE Healthcare, LLC II Jul-02-2014
16 NeuroLogica Corporation II Mar-02-2018
17 NeuroLogica Corporation II Aug-25-2017
18 Philips Electronics North America Corporation II Jan-03-2018
19 Philips Electronics North America Corporation II Jun-09-2017
20 Philips Electronics North America Corporation II Sep-01-2016
21 Philips Electronics North America Corporation II Feb-05-2016
22 Philips Healthcare II Jun-03-2016
23 Philips Medical Systems (Cleveland) Inc II Jan-11-2017
24 Philips Medical Systems Nederlands II May-03-2018
25 Philips Medical Systems, Inc. II Mar-31-2016
26 Philips Medical Systems, Inc. II Dec-03-2015
27 Philips Medical Systems, Inc. II May-19-2015
28 Philips Medical Systems, Inc. II Mar-06-2015
29 Philips North America, LLC II Mar-23-2019
30 Shimadzu Medical Systems Usa Com II Jun-29-2017
31 Siemens Medical Solutions USA, Inc II Oct-30-2018
32 Siemens Medical Solutions USA, Inc II Oct-30-2018
33 Siemens Medical Solutions USA, Inc II Oct-04-2016
34 Siemens Medical Solutions USA, Inc II May-23-2015
35 Siemens Medical Solutions USA, Inc II May-05-2015
36 Siemens Medical Solutions USA, Inc II Jan-16-2015
37 Siemens Medical Solutions USA, Inc II Oct-02-2014
38 Siemens Medical Solutions USA, Inc II Sep-23-2014
39 Siemens Medical Solutions USA, Inc II Jun-21-2014
40 Siemens Medical Solutions USA, Inc II Jun-04-2014
41 Siemens Medical Solutions USA, Inc II Apr-24-2014
42 Swissray II Sep-25-2018
43 Swissray II Sep-18-2018
44 Visaris DOO II May-15-2018

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