Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette
FDA 510(k) K023020 · Agfa Corp.
510(k) numberK023020
Submission
- Device name
- Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette
- Applicant
- Agfa Corp.
Greenville, SC, US - Received
- September 11, 2002
- Decision date
- September 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K013229 | Liferay FW Mammo Cassette, Liferay KW Mammo CasetteIXA · Traditional | Ferrania USA, Inc. | 10/12/2001SE |
| K012373 | Liferay WL Cassette, Liferay KW CassetteIXA · Traditional | Ferrania S.P.A. | 08/09/2001SE |
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| K053458 | WEB1000LLZ · Traditional | 12/22/2005SE |
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| K050810 | Agfa CR50.0MQB · Special | 04/21/2005SE |
| K050751 | Impax Orthopaedic Workstation, Model Impax Es 5.XLLZ · Special | 04/21/2005SE |
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Questions and answers
When was Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette cleared by the FDA?
Agfa Mamoray Mammographic Cassette, Agfa Metal-Bodied Cawo Cassette, Agfa Curix and Lightweight Cassette (K023020) received a 510(k) decision of Substantially Equivalent on September 26, 2002, 15 days after the submission was received.
What is the product code of K023020?
The FDA product code is IXA – Cassette, Radiographic Film, a Class II (moderate risk) device regulated under 21 CFR 892.1850.