Panels › Obstetrics/Gynecology › Product code HEM · Class 2

Imager, Ultrasonic Obstetric-Gynecologic

Regulation 884.2225

0510(k)s in 12 months (30 all time)

0recalls in 12 months (1 all time)

0recalls that name a 510(k)

Top companies in HEM

Company	510(k)s	Recalls
General Electric Co.	4	0
Advanced Technology Laboratories, Inc.	2	0
Corometrics Medical Systems, Inc.	2	0
Digisonics, Inc.	1	1
Ge Medical Systems Information Technologies	2	0
Air-Shields, Inc.	1	0
Ausonics Pty , Ltd.	1	0
Elscint, Inc.	1	0
Fukuda Denshi USA, Inc.	1	0
International Biomedics, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Apr 26, 2011	Digisonics, Inc OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098 OBLink provides automated transmission of patient data and measurements from ultrasound systems directly to D Terminated	HEM	None listed

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