GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
FDA 510(k) clearance K032795 · decided 2003-10-08
Clearance details
- K-number
- K032795
- Device name
- GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2003-09-08
- Decision date
- 2003-10-08
- Days to decision
- 30 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 |
|---|---|---|
| 7) Signa OpenSpeed (K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System) The 0.7T Signa recall (Z-1430-2011) | GE Healthcare, LLC | 2011-02-24 |
| Signa OpenSpeed, 0.7T MR Systems (HFO3-5). recall (Z-0425-2011) | GE Healthcare, LLC | 2010-11-19 |
| Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (237 recall (Z-1723-2009) | GE Medical Systems, LLC | 2009-08-25 |
| GE Signa OpenSpeed 0.7T MR System. The 0.7T Signa OpenSpeed with Excite Magnetic Resonance recall (Z-1557-2009) | GE Medical Systems, LLC | 2009-06-30 |