ECAT SCANNER (MODEL 921)
FDA 510(k) clearance K913637 · decided 1991-11-27
Clearance details
- K-number
- K913637
- Device name
- ECAT SCANNER (MODEL 921)
- Applicant
- Cti Pet Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-15
- Decision date
- 1991-11-27
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Knoxville, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cti Pet Systems
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
| Record | Firm | Date |
|---|---|---|
| ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positr recall (Z-0674-03) | Cti Pet Systems Inc | 2003-03-21 |