GE Medical Systems Ultrasound and Primary Care Dia
Milwaukee, WI, US
Ge Medical Systems Ultrasound and Primary Care Dia appears in FDA device records in Milwaukee, WI. FDA records list 7 510(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
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for GE Medical Systems Ultrasound and Primary Care Dia between 2004 and 2011. The busiest year on record is 2007, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | KGI | Substantially Equivalent | |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | KGI | Substantially Equivalent | |
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | IYO | Substantially Equivalent | |
| K073408 | GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | Substantially Equivalent | |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | KGI | Substantially Equivalent | |
| K052581 | LUNAR IDXA | KGI | Substantially Equivalent | |
| K041813 | GE LOGIQ 7 ULTRASOUND BT04 | IYN | 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