Sim&Size Version 1.0.5
by Sim&Cure
Sim&Size Version 1.0.5 is a Class II device made by Sim&Cure, cleared under FDA 510(k) K190049 on 17 Sep 2019 and listed in FDA GUDID since 30 Jul 2020 (UDI-DI 03665786000025), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03665786000025 | Date30 Jul 2020 | StatusListed |
| United States | FDA 510(k) | NumberK190049 | Date17 Sep 2019 | StatusActive |
Official records
- AccessGUDID record 03665786000025
- FDA 510(k) database K190049
Across registries
- FDA 510(k) K190049 decided 17 Sep 2019 Active
- FDA GUDID UDI-DI 03665786000025 listed 30 Jul 2020 Listed
Timeline
- Cleared FDA 510(k) K190049
- Listed FDA GUDID 03665786000025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sim&Size
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- Version 1.0.5
- Primary DI / UDI-DI
- 03665786000025
- 510(k) Number
- FDA product code
- PZO
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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