Contour Mammography System, Model Number M-Ctr
FDA 510(k) K925725 · Bennett X-Ray Corp.
510(k) numberK925725
Submission
- Device name
- Contour Mammography System, Model Number M-Ctr
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- November 13, 1992
- Decision date
- February 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K945731 | HFQ High Frequency Radiographic and Fluroscopic GeneratorsIZO · Traditional | 02/15/1995SE |
| K940701 | Bennett Mammography Positioning Chair Model No. M-PchIZH · Traditional | 04/28/1994SE |
| K935649 | Whis-Rad Tubstand Structure/Mobile Patient TrolleyKPR · Traditional | 02/09/1994SE |
| K935068 | Radiographic Generator Hfq-WhisIZO · Traditional | 12/13/1993SE |
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Questions and answers
When was Contour Mammography System, Model Number M-Ctr cleared by the FDA?
Contour Mammography System, Model Number M-Ctr (K925725) received a 510(k) decision of Substantially Equivalent on February 26, 1993, 105 days after the submission was received.
What is the product code of K925725?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.