Single Phase Diag. X-Ray Generator Micro-X 650
FDA 510(k) K880519 · Fischer Imaging Corp.
510(k) numberK880519
Submission
- Device name
- Single Phase Diag. X-Ray Generator Micro-X 650
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- February 9, 1988
- Decision date
- May 4, 1988
- 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 |
|---|---|---|
| K042095 | MammotestIZH · Traditional | 10/29/2004SE |
| K021113 | MammopathMWP · Traditional | 06/13/2002SE |
| K981414 | LC PositionerJAA · Traditional | 07/16/1998SE |
| K973400 | Mammotest Adapter DriverIZH · Traditional | 11/10/1997SE |
| K964806 | MD-1835IXL · Traditional | 03/04/1997SE |
| K961207 | Ep-X BiplaneJAA · Traditional | 08/20/1996SE |
| K961022 | Tangent Vi TableIXR · Traditional | 05/03/1996SE |
| K950291 | Digital 625HFIZO · Traditional | 03/23/1995SE |
| K945619 | Athena HFXIZH · Traditional | 03/23/1995SE |
| K944150 | Micro X-65 HFIZO · Traditional | 09/16/1994SE |
Questions and answers
When was Single Phase Diag. X-Ray Generator Micro-X 650 cleared by the FDA?
Single Phase Diag. X-Ray Generator Micro-X 650 (K880519) received a 510(k) decision of Substantially Equivalent on May 4, 1988, 85 days after the submission was received.
What is the product code of K880519?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.