VISION (NUCLEAR MEDICINE COMPUTER)
FDA 510(k) clearance K912573 · decided 1991-10-28
Clearance details
- K-number
- K912573
- Device name
- VISION (NUCLEAR MEDICINE COMPUTER)
- Applicant
- Summit Nuclear
- Decision
- Substantially Equivalent
- Date received
- 1991-06-11
- Decision date
- 1991-10-28
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Twinsburg, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.