Mam-Cp X-Ray Apparatus
FDA 510(k) K872980 · Transworld X-Ray Corp.
510(k) numberK872980
Submission
- Device name
- Mam-Cp X-Ray Apparatus
- Applicant
- Transworld X-Ray Corp.
Charlotte, NC, US - Received
- July 30, 1987
- Decision date
- August 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Mam-Cp X-Ray Apparatus cleared by the FDA?
Mam-Cp X-Ray Apparatus (K872980) received a 510(k) decision of Substantially Equivalent on August 27, 1987, 28 days after the submission was received.
What is the product code of K872980?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.