Identity
- Trade Name
- SXR / Saevo FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Device Name
- Tomography only (MFOV) FDA UDI
- Model / Reference
- AXR120 B FDA UDI
- Description
- Tomography only (MFOV) FDA UDI
Identifiers
- Catalog Number
- 16000004380 FDA UDI
- Primary DI / UDI-DI
- 07899581340789 FDA UDI
- 510(k) Number
- K223816 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Cone beam computed tomography system, head/neck FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Cone beam computed tomography system, head/neck
A comprehensive medical device directory listing the SXR / Saevo Cone Beam Computed Tomography system.
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Cleared under the same submission
K223816 also covers:
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- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
- Dental CT Scanner AXR — ALLIAGE S/A INDÚSTRIAS MÉDICO ODONTOLÓGICA
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alliage S/A Indústrias Médico Odontológica
Sources (1)
- FDA UDI 42dfd224-87f5-42e7-83cd-d6def2b046fb 36 fields · synced Jul 31, 2026