Opdima Digital Mammographic X-Ray System
FDA 510(k) K072392 · Siemens Medical Solutions USA, Inc.
510(k) numberK072392
Submission
- Device name
- Opdima Digital Mammographic X-Ray System
- Applicant
- Siemens Medical Solutions USA, Inc.
Mavern, PA, US - Received
- August 27, 2007
- Decision date
- September 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Opdima Digital Mammographic X-Ray System cleared by the FDA?
Opdima Digital Mammographic X-Ray System (K072392) received a 510(k) decision of Substantially Equivalent on September 25, 2007, 29 days after the submission was received.
What is the product code of K072392?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.