1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
FDA 510(k) clearance K052621 · decided 2005-10-07
Clearance details
- K-number
- K052621
- Device name
- 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
- Applicant
- Usa Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-23
- Decision date
- 2005-10-07
- Days to decision
- 14 days
- Clearance type
- Special
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aurora, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System. recall (Z-0163-2007) | USA Instruments Incorporated | 2006-11-09 |