Single Phase X-Ray Controls & HV Generators
FDA 510(k) K760568 · Litton Medical Systems
510(k) numberK760568
Submission
- Device name
- Single Phase X-Ray Controls & HV Generators
- Applicant
- Litton Medical Systems
Mchenry, IL, US - Received
- September 2, 1976
- Decision date
- September 15, 1976
- 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 |
|---|---|---|
| K770338 | X-Ray Control & X-Ray HV GeneratorIZO · Traditional | 03/01/1977SE |
| K770337 | Fluoroscopic Assembly, Image Intens.JAA · Traditional | 03/01/1977SE |
| K770336 | X-Ray Tube, Rotating AnodeITY · Traditional | 03/01/1977SE |
| K770334 | Tilting X-Ray TableIXR · Traditional | 03/01/1977SE |
| K770333 | Fluoroscope, C-ArmJAA · Traditional | 03/01/1977SE |
| K770335 | Collimator, AutomaticKPW · Traditional | 02/28/1977SE |
| K760569 | Three Phase X-Ray Controls & HV GeneratorsIZO · Traditional | 09/15/1976SE |
Questions and answers
When was Single Phase X-Ray Controls & HV Generators cleared by the FDA?
Single Phase X-Ray Controls & HV Generators (K760568) received a 510(k) decision of Substantially Equivalent on September 15, 1976, 13 days after the submission was received.
What is the product code of K760568?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.