VPW2877E7 X Ray Power Supply
FDA 510(k) K905855 · Varian Canada, Inc.
510(k) numberK905855
Submission
- Device name
- VPW2877E7 X Ray Power Supply
- Applicant
- Varian Canada, Inc.
Canada L7g 2j4, CA - Received
- December 21, 1990
- Decision date
- February 13, 1991
- 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 |
|---|---|---|
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | 09/26/1995SE |
| K923455 | HFG 350, 650, 1050KPR · Traditional | 12/28/1992SE |
| K920938 | VJW2919 Pneumatic Compression UpgradeIZH · Traditional | 06/17/1992SE |
| K913234 | VPW2906A1: 480V, 3 Phase, X-Ray Power SupplyIZO · Traditional | 09/23/1991SE |
| K910820 | VPW 2877E6 X-Ray Power SupplyIZO · Traditional | 03/07/1991SE |
| K904169 | VPW 2903 A-1 -208V, B2-440V,C3-240V X-Ray SupplyIZO · Traditional | 02/19/1991SE |
Questions and answers
When was VPW2877E7 X Ray Power Supply cleared by the FDA?
VPW2877E7 X Ray Power Supply (K905855) received a 510(k) decision of Substantially Equivalent on February 13, 1991, 54 days after the submission was received.
What is the product code of K905855?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.