Radkor SFR-70
FDA 510(k) K883864 · Radkor, Inc.
510(k) numberK883864
Submission
- Device name
- Radkor SFR-70
- Applicant
- Radkor, Inc.
Irvine, CA, US - Received
- September 13, 1988
- Decision date
- October 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935123 | Superstand 300IYB · Traditional | Wuestec Medical, Inc. | 03/27/1996SE |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000IYB · Traditional | Scott Imaging Intl., Inc. | 02/15/1995SE |
| K941017 | F/C/W TubestandIYB · Traditional | Acoma Medical Imaging, Inc. | 07/29/1994SE |
| K941004 | CTS SystemIYB · Traditional | Acoma Medical Imaging, Inc. | 07/29/1994SE |
| K940442 | MPR-814IYB · Traditional | Xri, Inc. | 06/09/1994SE |
| K935004 | Model Alpha TS-2IYB · Traditional | Dpa Consulting, Inc. | 12/13/1993SE |
| K933253 | Superstand 3000IYB · Traditional | Wuestec Medical, Inc. | 08/16/1993SE |
| K925716 | Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional | Bennett X-Ray Corp. | 12/17/1992SE |
| K925170 | Shimadzu X-Ray Tube Stand BH-100 SeriesIYB · Traditional | Shimadzu Medical Systems | 12/07/1992SE |
| K920727 | Ceiling Tube Support CH-30XIYB · Traditional | Shimadzu Medical Systems | 04/16/1992SE |
More from Shimadzu Medical Systems
| 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 |
| K881701 | Radkor SFC-21IYB · Traditional | 09/08/1988SE |
| K883081 | Radkor, XG-515IZO · Traditional | 09/02/1988SE |
| 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 SFR-70 cleared by the FDA?
Radkor SFR-70 (K883864) received a 510(k) decision of Substantially Equivalent on October 19, 1988, 36 days after the submission was received.
What is the product code of K883864?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.