TPLC - Total Product Life Cycle

• Device: system, imaging, pulsed doppler, ultrasonic
• Regulation Description: Ultrasonic pulsed doppler imaging system.
• Product Code: IYN
• Regulation Number: 892.1550
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	17
ACUSON
	SUBSTANTIALLY EQUIVALENT	7
AGILENT TECHNIOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
ATL ULTRASOUND, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
EDAN INSTRUMENTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EP MEDSYSTEMS
	SUBSTANTIALLY EQUIVALENT	2
ESAOTE
	SUBSTANTIALLY EQUIVALENT	13
FUKUDA DENSHI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	51
HEWLETT-PACKARD CO.
	SUBSTANTIALLY EQUIVALENT	8
HITACHI MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	9
HUNTLEIGH HEALTHCARE LTD.
	SUBSTANTIALLY EQUIVALENT	1
LARSEN & TOUBRO LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LIFE-TECH INT'L., INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDASONICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDISON
	SUBSTANTIALLY EQUIVALENT	9
NICOLET BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS
	SUBSTANTIALLY EQUIVALENT	4
PENTAX
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	6
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	14
SIEMENS
	SUBSTANTIALLY EQUIVALENT	40
SONOSITE,INC.
	SUBSTANTIALLY EQUIVALENT	16
TOSHIBA
	SUBSTANTIALLY EQUIVALENT	26
VIASYS HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
No Known Device Problem	2
No display or display failure	1
Total Device Problems	3

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	4	13	1	4	16	4	2
Class III	1	1	0	1	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	B & K Medical Systems, Inc.	II	Jun-10-2008
2	Bard Access Systems	II	Jul-11-2011
3	Boston Scientific Corporation	II	Sep-17-2008
4	Cardinal Health, Inc	II	Apr-07-2009
5	GE Healthcare Clinical Systems	II	Jun-12-2008
6	GE Healthcare, LLC	II	Apr-11-2013
7	GE Healthcare, LLC	II	Feb-23-2012
8	GE Healthcare, LLC	II	Jan-21-2012
9	GE Healthcare, LLC	II	Jan-11-2012
10	Hitachi Medical Systems America Inc	II	Jun-08-2011
11	Philips Medical Systems	II	Dec-31-2008
12	Philips Medical Systems	II	Sep-16-2008
13	Philips Medical Systems	II	Jul-03-2007
14	Philips Medical Systems Nederlands	II	Apr-25-2011
15	Philips Ultrasound, Inc.	II	Feb-17-2007
16	Siemens Medical Solutions USA, Inc.	II	Apr-10-2013
17	Siemens Medical Solutions USA, Inc.	II	May-16-2012
18	Siemens Medical Solutions USA, Inc.	II	May-06-2011
19	Siemens Medical Solutions USA, Inc.	II	Apr-29-2011
20	Siemens Medical Solutions USA, Inc.	II	Apr-25-2011
21	Siemens Medical Solutions USA, Inc.	II	Apr-22-2011
22	Siemens Medical Solutions USA, Inc.	II	Apr-08-2011
23	Siemens Medical Solutions USA, Inc.	II	Mar-30-2011
24	Siemens Medical Solutions USA, Inc.	II	Mar-28-2011
25	Siemens Medical Solutions USA, Inc.	II	Feb-01-2011
26	Siemens Medical Solutions USA, Inc.	II	Dec-28-2010
27	Siemens Medical Solutions USA, Inc.	II	Oct-10-2008
28	Siemens Medical Solutions USA, Inc.	II	Oct-08-2008
29	Siemens Medical Solutions USA, Inc.	II	Sep-29-2008
30	Siemens Medical Solutions USA, Inc.	II	Sep-19-2008
31	Siemens Medical Solutions USA, Inc.	III	Sep-02-2008
32	Siemens Medical Solutions USA, Inc.	II	Apr-24-2008
33	Siemens Medical Solutions USA, Inc.	II	Feb-15-2008
34	Siemens Medical Solutions USA, Inc.	II	Jan-09-2008
35	Siemens Medical Solutions USA, Inc., Mountain View, CA	II	Mar-28-2011
36	Sonosite, Inc.	II	Oct-18-2011
37	Sonosite, Inc.	III	Nov-26-2010
38	Sonosite, Inc.	II	Oct-01-2010
39	Sonosite, Inc.	II	Aug-02-2010
40	Sonosite, Inc.	II	Mar-29-2007
41	Toshiba American Med Sys Inc	II	Jan-09-2008
42	Toshiba American Med Sys Inc	III	Nov-17-2007
43	Toshiba American Med Sys Inc	II	Jun-27-2007
44	Toshiba American Medical Systems Inc	II	Jul-29-2011
45	Toshiba American Medical Systems Inc	II	May-19-2011
46	Toshiba American Medical Systems Inc	II	May-10-2011
47	Toshiba American Medical Systems Inc	II	Mar-19-2010