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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, ultrasonic, diagnostic
Regulation Description Diagnostic ultrasonic transducer.
Product CodeITX
Regulation Number 892.1570
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 8
ACUSON
  SUBSTANTIALLY EQUIVALENT 11
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATL ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
CIVCO
  SUBSTANTIALLY EQUIVALENT 12
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
FUJI
  SUBSTANTIALLY EQUIVALENT 1
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 21
GYNESONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 7
HITACHI MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
HUNTLEIGH HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  1
  SUBSTANTIALLY EQUIVALENT 2
KOVEN TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
KRETZTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 4
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDISON
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 10
PENTAX
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 6
SHIMADZU CORP.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 7
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
SONOSITE,INC.
  SUBSTANTIALLY EQUIVALENT 2
TOSHIBA
  SUBSTANTIALLY EQUIVALENT 19
VASCULAR CONTROL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Device displays error message 202
Use of Device Issue 23
Incorrect or inadequate result 20
Electrical issue 20
Poor quality image 19
Computer software issue 18
Bacterial contamination of device 17
Device operates differently than expected 16
Detachment of device component 15
Break 13
Disinfection or Sterilization Issue at User Location 13
Split 12
Data Issue 12
Low readings 10
False negative result 10
Invalid sensing 9
Temperature issue 9
Output issue 8
Entrapment of device or device component 8
Artifact 8
Fracture 8
Detachment of device or device component 7
No Information 7
No Known Device Problem 6
Retraction problem 6
Difficult to remove 6
Overheating of device or device component 6
Mechanical issue 5
Improper device output 5
No code available 4
Material puncture 4
Material separation 4
Incorrect or inadequate test results 4
No display or display failure 4
Loss of or failure to bond 3
Crack 3
Low test results 3
Connection issue 3
Residue after decontamination 3
Foreign material present in device 3
Device or device component damaged by another device 3
Issue with displayed error message 2
Device handling issue 2
Failure to sense 2
Smoking 2
Tip breakage 2
Computer system security issue 2
Material perforation 2
Failure to disconnect 2
Physical resistance 2
Defective item 2
Performance 2
Difficult to position 2
Normal 2
Leak 2
Fluid leak 2
Hole in material 2
Image resolution poor 1
Excess flow or overinfusion 1
Difficult to insert 1
Difficult to flush 1
Material fragmentation 1
Grounding malfunction 1
Loose or intermittent connection 1
Incorrect measurement 1
Unsealed device packaging 1
Difficult to deploy 1
Design/structure problem 1
Failure to disinfect 1
Erratic display 1
Coiled 1
Component(s), broken 1
Contamination during use 1
Fire 1
High Readings 1
Failure to align 1
Spark 1
Device inoperable 1
Product quality issue 1
Device remains activated 1
Improper or incorrect procedure or method 1
Device Issue 1
Failure to calibrate 1
Positioning Issue 1
Torn material 1
Not Applicable 1
Material Protrusion 1
Device sensing issue 1
Electrical overstress 1
Electronic property issue 1
Total Device Problems 624

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 2 2 6 1 1 2 2 1 0
Class III 0 1 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jan-30-2014
2 Boston Scientific Corporation II Jan-28-2009
3 Civco Medical Instruments Co. Inc. II Nov-17-2015
4 Civco Medical Instruments Inc II Apr-08-2015
5 Civco Medical Instruments Inc II Mar-08-2011
6 Civco Medical Instruments Inc II Aug-20-2010
7 Civco Medical Instruments Inc III Mar-19-2008
8 Hitachi Medical Systems America Inc II Sep-09-2009
9 Pentax Medical Company II Jun-28-2016
10 Pentax Medical Company II May-03-2012
11 Siemens Medical Solutions USA, Inc. II Sep-03-2014
12 Siemens Medical Solutions USA, Inc. II Apr-12-2011
13 Siemens Medical Solutions USA, Inc. II Feb-22-2011
14 Siemens Medical Solutions USA, Inc. II Feb-01-2011
15 Siemens Medical Solutions USA, Inc. II Jan-12-2011
16 Siemens Medical Solutions USA, Inc., Mountain View, CA II Mar-28-2011
17 Toshiba American Med Sys Inc II May-05-2007
18 Toshiba American Medical Systems Inc II Apr-12-2013
19 Toshiba American Medical Systems Inc II Jul-13-2010
20 Verathon, Inc. III Oct-26-2010

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