PreXion3D Eclipse XP77
by Yoshida Dental Mfg. Co., Ltd., the
PreXion3D Eclipse XP77 is a Class II device made by Yoshida Dental Mfg. Co., Ltd., the, cleared under FDA 510(k) K122199 on 18 Apr 2013 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 04547497757049), 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 | Number04547497757049 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122199 | Date18 Apr 2013 | StatusActive |
Official records
- AccessGUDID record 04547497757049
- FDA 510(k) database K122199
Across registries
- FDA 510(k) K122199 decided 18 Apr 2013 Active
- FDA GUDID UDI-DI 04547497757049 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K122199
- Listed FDA GUDID 04547497757049
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PreXion3D Eclipse
- Generic name
- Limited-view-field CT system
- Model / reference
- XP77
- Primary DI / UDI-DI
- 04547497757049
- 510(k) Number
- FDA product code
- OAS
- GMDN term
- Limited-view-field CT system
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
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