RadCalc Software
510(k) K193381
RadCalc Software is a Class II device made by LifeLine Software, cleared under FDA 510(k) K193381 on 31 Dec 2019, active as of 8 Nov 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 | NumberK193381 | Date31 Dec 2019 | StatusActive |
Official records
- FDA 510(k) database K193381
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- FDA applicant
- Lifeline Software, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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