ECAT PET SCANNER
FDA 510(k) clearance K002715 · decided 2000-10-31
Clearance details
- K-number
- K002715
- Device name
- ECAT PET SCANNER
- Applicant
- Cti Pet Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-31
- Decision date
- 2000-10-31
- Days to decision
- 61 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomo recall (Z-0547-05) | CTI PET Systems Inc | 2005-02-16 |
| Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT recall (Z-0106-04) | Cti Pet Systems Inc | 2003-11-13 |