Cardiac First Pass Analysis
510(k) K921777
Cardiac First Pass Analysis is a medical device (FDA Class II; FDA product code KPS, System, Tomography, Computed, Emission) made by GE Medical Systems, cleared under FDA 510(k) K921777 on 12 Aug 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK921777 | Date12 Aug 1992 | StatusActive |
Official records
- FDA 510(k) database K921777
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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