ECAT SCANNER (MODEL 921)— 510(k) K913637
Substantially EquivalentCti Pet Systems, Inc.
FDA 510(k) clearance K913637 for ECAT SCANNER (MODEL 921), Substantially Equivalent on 1991-11-27. Applicant: Cti Pet Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cti Pet Systems, Inc.
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Knoxville, TN, US
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