MULTILEAF INTENSITY MODULATING COLLIMATOR
FDA 510(k) clearance K940412 · decided 1995-02-15
Clearance details
- K-number
- K940412
- Device name
- MULTILEAF INTENSITY MODULATING COLLIMATOR
- Applicant
- Nomos Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-27
- Decision date
- 1995-02-15
- Days to decision
- 384 days
- Clearance type
- Traditional
- Product code
- IXI
- Device class
- 2
- Regulation number
- 892.5710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sewickley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.