Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix…
FDA 510(k)Class II (US FDA 510(k))
by Agfa Corp.
Identifiers
- 510(k) Number
- K023020 FDA 510(k)
- FDA Product Code
- IXA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1850 FDA 510(k)
- Regulation Number
- 892.1850 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a cassette, radiographic film, designed as a lightproof enclosure for radiographic film. It maintains close contact between film and x-ray intensifying screens during diagnostic x-ray procedures.
The device is supplied as a reusable product and is authorized under FDA 510(k) clearance K023020. It is classified as a Class II medical device with product code IXA and regulation number 892.1850, and is intended for use in radiology settings.
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: Agfa Corporate, Agfa Mamoray Mammographic Cassette, Agfa Metal-bodied Cawo Cassette ..., K023020 FDA 510 (k) - AGFA MAMORAY MAMMOGRAPHIC CASSETTE, Agfa Mamoray Mammographic Cassette, Agfa Metal-bodied Cawo Cassette ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023020 | Class II | Active |
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Manufacturer
- Manufacturer
- Agfa Corp.
Sources (1)
- FDA 510(k) K023020 24 fields · synced Sep 28, 2026