Identifiers
- 510(k) Number
- K093572 FDA 510(k)
- FDA Product Code
- IZW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1610 FDA 510(k)
- Regulation Number
- 892.1610 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The R650 Qdasm Collimator is an automatic beam limiting device designed for use in X-ray diagnostic radiographic and fluoroscopic applications. It functions to control the X-ray beam to ensure proper exposure during imaging procedures.
This Class II medical device is regulated under 21 CFR 892.1610 and received FDA 510(k) clearance in 2010 under K093572. It is manufactured by Omega Medical Imaging, Inc. and is designed to comply with international safety standards including IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-3.
Frequently asked questions
What is the primary function of the R650 Qdasm Collimator?
The R650 Qdasm is an automatic beam limiting device used in X-ray diagnostic radiographic and fluoroscopic applications. Its purpose is to control the X-ray beam to ensure proper exposure during imaging procedures.
What regulatory standards does this device meet?
The device is designed to comply with international safety standards, specifically IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-3. It is classified as a Class II medical device under 21 CFR 892.1610 and received FDA 510(k) clearance in 2010 under K093572.
Who is the manufacturer of the R650 Qdasm Collimator?
The R650 Qdasm Collimator is manufactured by Omega Medical Imaging, Inc., located in Sanford, Florida.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF OMEGA MEDICAL IMAGING, INC. 7 & 510(k) SUMMARY, Omega R650 Qdasm Collimator - allmed.wiki, FDA Browser - Cleared 510 (K) - R650 QDASM COLLIMATOR (K093572), Home - Omega Medical Imaging
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093572 | Class II | Active |
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Manufacturer
- Manufacturer
- Omega Medical Imaging, Inc.
Sources (1)
- FDA 510(k) K093572 24 fields · synced Sep 24, 2026