30KW High Freq. Radio. Gene. Models HFQ-30/HFQ30SE
FDA 510(k) K894479 · Bennett X-Ray Corp.
510(k) numberK894479
Submission
- Device name
- 30KW High Freq. Radio. Gene. Models HFQ-30/HFQ30SE
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- July 18, 1989
- Decision date
- September 12, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| 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 |
More from Scott Imaging Intl., Inc.
| 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 |
| K935068 | Radiographic Generator Hfq-WhisIZO · Traditional | 12/13/1993SE |
| K925725 | Contour Mammography System, Model Number M-CtrIZH · Traditional | 02/26/1993SE |
Questions and answers
When was 30KW High Freq. Radio. Gene. Models HFQ-30/HFQ30SE cleared by the FDA?
30KW High Freq. Radio. Gene. Models HFQ-30/HFQ30SE (K894479) received a 510(k) decision of Substantially Equivalent on September 12, 1989, 56 days after the submission was received.
What is the product code of K894479?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.