Mammotest Product, Modification
FDA 510(k) K926575 · Fischer Imaging Corp.
510(k) numberK926575
Submission
- Device name
- Mammotest Product, Modification
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- December 1, 1992
- Decision date
- March 30, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K961207 | Ep-X BiplaneJAA · Traditional | 08/20/1996SE |
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| K950291 | Digital 625HFIZO · Traditional | 03/23/1995SE |
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Questions and answers
When was Mammotest Product, Modification cleared by the FDA?
Mammotest Product, Modification (K926575) received a 510(k) decision of Substantially Equivalent on March 30, 1993, 119 days after the submission was received.
What is the product code of K926575?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.