Simplicit90Y 2.12
Simplicit90Y 2.12 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Mirada Medical, Ltd., cleared under FDA 510(k) K182016 on 6 Dec 2018 and listed in FDA GUDID since 26 Feb 2024 (UDI-DI B334SY2P120), 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 | NumberB334SY2P120 | Date26 Feb 2024 | StatusListed |
| United States | FDA 510(k) | NumberK182016 | Date6 Dec 2018 | StatusActive |
Official records
- FDA 510(k) database K182016
Across registries
- FDA 510(k) K182016 decided 6 Dec 2018 Active
- FDA GUDID UDI-DI B334SY2P120 listed 26 Feb 2024 Listed
Timeline
- Cleared FDA 510(k) K182016
- Listed FDA GUDID B334SY2P120
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Simplicit90Y
- Generic name
- Radiology picture archiving and communication system workstation
- Model / reference
- 2.12
- Primary DI / UDI-DI
- B334SY2P120
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology picture archiving and communication system workstation
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radiology picture archiving and communication system workstation.