Quantitative Heart
by Siemens Medical Solutions USA, Inc.
510(k) K940236
Quantitative Heart is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K940236 on 3 May 1994, 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 | NumberK940236 | Date3 May 1994 | StatusActive |
Official records
- FDA 510(k) database K940236
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- Withdrawn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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