GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
FDA 510(k) clearance K053009 · decided 2005-11-17
Clearance details
- K-number
- K053009
- Device name
- GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-10-26
- Decision date
- 2005-11-17
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0. recall (Z-1209-2013) | GE Healthcare, LLC | 2013-05-01 |
| GE Healthcare Signa Ovation 0.35T, Model Numbers: Ovation 1-3 (2276937), Ovation 4 (237706 recall (Z-1722-2009) | GE Medical Systems, LLC | 2009-08-25 |
| GE Signa Ovation 0.35 T MR System. The Signa Ovation System is an open, whole body scanner recall (Z-1556-2009) | GE Medical Systems, LLC | 2009-06-30 |