ImmersiveAR V2.0
ImmersiveAR V2.0 (IMAR20) is a Class II device made by ImmersiveTouch, Inc., cleared under FDA 510(k) K230249 on 16 Oct 2023 and listed in FDA GUDID since 17 Sep 2026 (UDI-DI B940IMAR200), 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 | NumberB940IMAR200 | Date17 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230249 | Date16 Oct 2023 | StatusActive |
Official records
- FDA 510(k) database K230249
Across registries
- FDA 510(k) K230249 decided 16 Oct 2023 Active
- FDA GUDID UDI-DI B940IMAR200 listed 17 Sep 2026 Listed
Timeline
- Cleared FDA 510(k) K230249
- Listed FDA GUDID B940IMAR200
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ImmersiveAR
- Generic name
- Multi-specialty anatomical modelling radiology software
- Model / Ref / Catalog
- V2.0, IMAR20
- Primary DI / UDI-DI
- B940IMAR200
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Multi-specialty anatomical modelling radiology software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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