Bennett X-Ray Tomography System
FDA 510(k) K945749 · Bennett X-Ray Corp.
510(k) numberK945749
Submission
- Device name
- Bennett X-Ray Tomography System
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- November 23, 1994
- Decision date
- February 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
| K964576 | Profile Mammography System (M-Pro)IZH · Traditional | 01/10/1997SE |
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| K944978 | Bennett X-Ray Digital Spot Imaging System Model M-DsiIZH · Traditional | 05/03/1995SE |
| K945962 | Bennett X-Ray Profile Positioning Paddle for MammographyIZH · Traditional | 04/03/1995SE |
| 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 |
| K925725 | Contour Mammography System, Model Number M-CtrIZH · Traditional | 02/26/1993SE |
| K925716 | Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional | 12/17/1992SE |
Questions and answers
When was Bennett X-Ray Tomography System cleared by the FDA?
Bennett X-Ray Tomography System (K945749) received a 510(k) decision of Substantially Equivalent on February 15, 1995, 84 days after the submission was received.
What is the product code of K945749?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.