Radiographic Generator Hfq-Whis
FDA 510(k) K935068 · Bennett X-Ray Corp.
510(k) numberK935068
Submission
- Device name
- Radiographic Generator Hfq-Whis
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- October 25, 1993
- Decision date
- December 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
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| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K964576 | Profile Mammography System (M-Pro)IZH · Traditional | 01/10/1997SE |
| K952672 | Vertical Integrated Perfect View (Vip) Radiographic SystemKPR · Traditional | 07/13/1995SE |
| 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 |
| K945749 | Bennett X-Ray Tomography SystemIZF · Traditional | 02/15/1995SE |
| 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 |
| 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 Radiographic Generator Hfq-Whis cleared by the FDA?
Radiographic Generator Hfq-Whis (K935068) received a 510(k) decision of Substantially Equivalent on December 13, 1993, 49 days after the submission was received.
What is the product code of K935068?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.