Sis 2000 Mammographic X-Ray System
FDA 510(k) K885127 · Fischer Imaging Corp.
510(k) numberK885127
Submission
- Device name
- Sis 2000 Mammographic X-Ray System
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- December 12, 1988
- Decision date
- February 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Sis 2000 Mammographic X-Ray System cleared by the FDA?
Sis 2000 Mammographic X-Ray System (K885127) received a 510(k) decision of Substantially Equivalent on February 16, 1989, 66 days after the submission was received.
What is the product code of K885127?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.