510(k) K993037 ยท OWB Interventional Fluoroscopic X-Ray System
LCV+ VERSION 2
| Applicant | Ge Medical Systems, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Feb 14, 2000 |
| Received | Sep 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993037
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2013 | GE Healthcare, LLC GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ.
Intended for general purpose diagnostic fluoroscopy and radiography studies. Terminated |
OWB | None listed |
| Nov 16, 2010 | GE Healthcare, LLC Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. , GE Healthcare, Waukesha, WI 53188 ( The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector Terminated |
MQB | None listed |
| Nov 16, 2010 | GE Healthcare, LLC Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
The Innova systems are indicated for use in generating fluoroscopic images of hum Terminated |
MQB | None listed |
| Aug 19, 2010 | GE Healthcare, LLC Innova 2000, manufactured by GE Medical Systems, SCS Terminated |
MQB | None listed |
| Jan 13, 2010 | GE Medical Systems, LLC Omega IV and Omega V tables on GE Innova 2000 fluoroscopic x-ray system Terminated |
MQB | None listed |
| Sep 20, 2008 | GE Healthcare Innova 2000; The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
Indicated for use in generating fluoroscopic images of human anatomy for vascul Terminated |
MQB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.