MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
FDA 510(k) clearance K962061 · decided 1996-11-27
Clearance details
- K-number
- K962061
- Device name
- MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1996-05-28
- Decision date
- 1996-11-27
- Days to decision
- 183 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch GE Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1) Signa Lx ( K962061 Signa Horizon Cx) The Signa Horizon Cx System is indicated for use a recall (Z-1424-2011) | GE Healthcare, LLC | 2011-02-24 |