Identity
- Trade Name
- Varex Imaging FDA UDI
- Generic Name
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
- Device Name
- x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 10 series FDA UDI
- Model / Reference
- OPTICA10-01-017-001-OEM FDA UDI
- Description
- x-ray beam-limiting device, to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(Collimator) This is a device out of the Optica 10 series FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718755003383 FDA UDI
- FDA Product Code
- IZX FDA UDI
- GMDN Term
- Manual-aperture-control diagnostic x-ray system collimator, non-motorized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1610 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual-aperture-control diagnostic x-ray system collimator, non-motorized
Varex Imaging by Varex Imaging Nederland B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual-aperture-control diagnostic x-ray system collimator, non-motorized.
- iRay — Iray Imaging Technology (Haining) Limited · Class II
- Collimare — Collimare, LLC · Class II
- Collimare — Collimare, LLC · Class II
- Ralco srl — RALCO SRL · Class II
- Ralco srl — RALCO SRL · Class II
- iRay — Iray Imaging Technology (Haining) Limited · Class II
- R-20J — Shimadzu Corp. · Class II
- Ralco srl — RALCO SRL · Class II
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
- Varex Imaging Nederland B.V.
Sources (1)
- FDA UDI a2647113-4ab2-4238-ba71-46864069a27f 33 fields · synced May 30, 2026