Otoplan 3.1.0
Otoplan 3.1.0 (20072) is a Class II device made by CAScination AG, cleared under FDA 510(k) K242120 on 11 Apr 2025 and listed in FDA GUDID since 12 Jun 2025 (UDI-DI 07616962000212), 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 | Number07616962000212 | Date12 Jun 2025 | StatusListed |
| United States | FDA 510(k) | NumberK242120 | Date11 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 07616962000212
- FDA 510(k) database K242120
Across registries
- FDA 510(k) K242120 decided 11 Apr 2025 Active
- FDA GUDID UDI-DI 07616962000212 listed 12 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K242120
- Listed FDA GUDID 07616962000212
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Otoplan
- Generic name
- Radiology picture archiving and communication system workstation
- Model / Ref / Catalog
- 3.1.0, 20072
- Primary DI / UDI-DI
- 07616962000212
- 510(k) Number
- FDA product code
- QQE
- GMDN term
- Radiology picture archiving and communication system workstation
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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