Otoplan 2.0
Otoplan 2.0 (20072) is a Class II device made by CAScination AG, cleared under FDA 510(k) K220300 on 24 Jun 2022 and listed in FDA GUDID since 11 Jul 2022 (UDI-DI 07640167222414), 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 | Number07640167222414 | Date11 Jul 2022 | StatusListed |
| United States | FDA 510(k) | NumberK220300 | Date24 Jun 2022 | StatusActive |
Official records
- AccessGUDID record 07640167222414
- FDA 510(k) database K220300
Across registries
- FDA 510(k) K220300 decided 24 Jun 2022 Active
- FDA GUDID UDI-DI 07640167222414 listed 11 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K220300
- Listed FDA GUDID 07640167222414
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- Withdrawn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
- 2.0, 20072
- Primary DI / UDI-DI
- 07640167222414
- 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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