FAN BEAM COLLIMATOR
FDA 510(k) clearance K933256 · decided 1993-10-29
Clearance details
- K-number
- K933256
- Device name
- FAN BEAM COLLIMATOR
- Applicant
- Siemens Gammasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-06
- Decision date
- 1993-10-29
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- IYX
- Device class
- 1
- Regulation number
- 892.1100
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hoffman Estates, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.