EDDA TECHNOLOGY IQQA-Guide
EDDA TECHNOLOGY IQQA-Guide is a Class II device made by EDDA Technology, Inc., cleared under FDA 510(k) K151414 on 20 Nov 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00868466000237), active as of 22 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 | Number00868466000237 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK151414 | Date20 Nov 2015 | StatusActive |
Official records
- AccessGUDID record 00868466000237
- FDA 510(k) database K151414
Across registries
- FDA 510(k) K151414 decided 20 Nov 2015 Active
- FDA GUDID UDI-DI 00868466000237 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K151414
- Listed FDA GUDID 00868466000237
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Edda Technology
- Generic name
- Electromagnetic surgical navigation/tracking system
- Model / reference
- IQQA-Guide
- Primary DI / UDI-DI
- 00868466000237
- 510(k) Number
- FDA product code
- JAK
- GMDN term
- Electromagnetic surgical navigation/tracking system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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