Sim&Size V1.0.7
by Sim&Cure
Sim&Size V1.0.7 is a Class II device made by Sim&Cure, cleared under FDA 510(k) K202322 on 31 Dec 2020, registered in EUDAMED and listed in FDA GUDID since 6 Jun 2021 (UDI-DI 03665786000056), active as of 23 Oct 2026.
Active
CE MDR CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number03665786000056 | Date6 Jun 2021 | StatusListed |
| United States | FDA 510(k) GUDID | NumberK202322 | Date31 Dec 2020 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
- EUDAMED public site
- AccessGUDID record 03665786000056
- FDA 510(k) database K202322
Across registries
- FDA 510(k) K202322 decided 31 Dec 2020 Active
- EUDAMED Active
- FDA GUDID UDI-DI 03665786000056 listed 6 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K202322
- Listed FDA GUDID 03665786000056
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Sim&Size
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- V1.0.7
- Primary DI / UDI-DI
- 03665786000056
- 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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