Prexion Evolve AXR120
by Alliage S/A Indústrias Médico Odontológica 4 variants
Prexion Evolve AXR120 (16000004500) is a Class II device made by Alliage S/A Indústrias Médico Odontológica, cleared under FDA 510(k) K223816 on 7 Apr 2023 and listed in FDA GUDID since 8 Dec 2023 (UDI-DI 07899581345111), 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 | Number07899581345111 | Date8 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK223816 | Date7 Apr 2023 | StatusActive |
Official records
- AccessGUDID record 07899581345111
- FDA 510(k) database K223816
Across registries
- FDA 510(k) K223816 decided 7 Apr 2023 Active
- FDA GUDID UDI-DI 07899581345111 listed 8 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K223816
- Listed FDA GUDID 07899581345111
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Prexion Evolve
- Generic name
- Cone beam computed tomography system, head/neck
- Model / Ref / Catalog
- AXR120, 16000004500
- Description
- Tomography with Cephalostat (MFOV)
- Primary DI / UDI-DI
- 07899581345111
- 510(k) Number
- FDA product code
- OAS
- GMDN term
- Cone beam computed tomography system, head/neck
- Device class
- Class II
- Regulation number
- 892.1750
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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