GE 1.5T SIGNA HDE MR SYSTEM
FDA 510(k) clearance K052978 · decided 2005-11-09
Clearance details
- K-number
- K052978
- Device name
- GE 1.5T SIGNA HDE MR SYSTEM
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2005-10-24
- Decision date
- 2005-11-09
- Days to decision
- 16 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, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging devi recall (Z-1208-2013) | GE Healthcare, LLC | 2013-05-01 |
| Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa V recall (Z-0935-2013) | GE Healthcare, LLC | 2013-03-11 |
| 4) Signa HDe (K052978 GE 1.5T Signa HDe MR System) The GE Signa HDe MR system is a whole b recall (Z-1427-2011) | GE Healthcare, LLC | 2011-02-24 |
| Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY recall (Z-0592-2010) | GE Medical Systems, LLC | 2010-01-11 |