Radkor, XG-515
FDA 510(k) K883081 · Radkor, Inc.
510(k) numberK883081
Submission
- Device name
- Radkor, XG-515
- Applicant
- Radkor, Inc.
Irvine, CA, US - Received
- July 21, 1988
- Decision date
- September 2, 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 |
|---|---|---|
| K895969 | Radkor DXG-650RIZO · Traditional | 11/13/1989SE |
| K892196 | Radkor TS10-BIXQ · Traditional | 04/26/1989SE |
| K891395 | Radkor BS-10 and BS-10TIXY · Traditional | 04/03/1989SE |
| K883885 | Radkor, RF-159KXJ · Traditional | 10/19/1988SE |
| K883864 | Radkor SFR-70IYB · Traditional | 10/19/1988SE |
| K881701 | Radkor SFC-21IYB · Traditional | 09/08/1988SE |
| K881700 | Radkor KOB-84KXJ · Traditional | 09/02/1988SE |
| K881696 | Radkor XG-325IZO · Traditional | 09/02/1988SE |
| K882563 | Radkor, CST-18IYB · Traditional | 07/08/1988SE |
Questions and answers
When was Radkor, XG-515 cleared by the FDA?
Radkor, XG-515 (K883081) received a 510(k) decision of Substantially Equivalent on September 2, 1988, 43 days after the submission was received.
What is the product code of K883081?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.