GE Dec Medical Systems
Salt Lake City, UT, US
Ge Dec Medical Systems appears in FDA device records in Salt Lake City, UT. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for GE Dec Medical Systems between 1994 and 2000. The busiest year on record is 1994, with 2. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000221 | SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM | OWB | Substantially Equivalent | |
| K993687 | UROVIEW 2800 | OWB | Substantially Equivalent | |
| K992506 | MINI 6800 DIGITAL MOBILE C-ARM | OXO | Substantially Equivalent | |
| K974355 | INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS) | OWB | Substantially Equivalent | |
| K970063 | SERIES 7600 MOBILE DIGITAL C-ARM | OWB | Substantially Equivalent | |
| K963952 | SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM | OWB | Substantially Equivalent | |
| K950781 | COMPACT 7600 | JAA | Substantially Equivalent | |
| K951765 | SERIES 6600 DIGITAL MOBILE C-ARM | OXO | Substantially Equivalent | |
| K940295 | UROVIEW MODEL 2600 | JAA | Substantially Equivalent | |
| K936136 | UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE | JAA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain