Identity
- Trade Name
- Avanti FDA UDI
- Generic Name
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
- Device Name
- RTVue XR System w/ CAM w/ 120V Table w/ 45pt Fixation FDA UDI
- Model / Reference
- RTVue XR100-1 FDA UDI
- Description
- RTVue XR System w/ CAM w/ 120V Table w/ 45pt Fixation FDA UDI
Identifiers
- Catalog Number
- 700-48076-004 FDA UDI
- Primary DI / UDI-DI
- 00858848006001 FDA UDI
- 510(k) Number
- K153080 FDA UDI
- FDA Product Code
- OBO FDA UDIHLI FDA UDI
- GMDN Term
- Ophthalmic spectral-domain optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic spectral-domain optical coherence tomography system
Avanti by Optovue, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K153080 also covers:
- Avanti — OPTOVUE, INC.
- Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti — OPTOVUE, INC.
- RTVue XR Avanti Scanner — OPTOVUE, INC.
- RTVue XR Avanti Scanner — OPTOVUE, INC.
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 |
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Manufacturer
- Manufacturer
- Optovue, Inc.
Sources (1)
- FDA UDI 986f2263-6c68-4551-92d8-68af25a7e910 36 fields · synced Jun 7, 2026