S3D OTI Camera EMA0001
S3D OTI Camera EMA0001 is a Class II device made by Pathkeeper Surgical Ltd, cleared under FDA 510(k) K222355 on 8 Mar 2023 and listed in FDA GUDID since 12 Mar 2024 (UDI-DI 07290019120261), 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 | Number07290019120261 | Date12 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222355 | Date8 Mar 2023 | StatusActive |
Official records
- AccessGUDID record 07290019120261
- FDA 510(k) database K222355
Across registries
- FDA 510(k) K222355 decided 8 Mar 2023 Active
- FDA GUDID UDI-DI 07290019120261 listed 12 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K222355
- Listed FDA GUDID 07290019120261
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- S3D OTI Camera
- Generic name
- Optical surgical navigation/tracking system
- Model / reference
- EMA0001
- Primary DI / UDI-DI
- 07290019120261
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Optical surgical navigation/tracking system
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Optical surgical navigation device tracking system.