NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
FDA 510(k) clearance K091546 · decided 2009-06-24
Clearance details
- K-number
- K091546
- Device name
- NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
- Applicant
- Noras Mri Products GmbH
- Decision
- Substantially Equivalent
- Date received
- 2009-05-27
- Decision date
- 2009-06-24
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MOS
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hoechberg, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Noras Mri Products GmbH
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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
No recalls on record reference this clearance.