Radkor TS10-B
FDA 510(k) K892196 · Radkor, Inc.
510(k) numberK892196
Submission
- Device name
- Radkor TS10-B
- Applicant
- Radkor, Inc.
Irvine, CA, US - Received
- April 3, 1989
- Decision date
- April 26, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | Medtec, Inc. | 12/05/1997SE |
| K960083 | Movable Cantilevered Radiographic Table XRT 100, 200 & 300IXQ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K954225 | Med-Tec Hand GripIXQ · Traditional | Medtec, Inc. | 11/14/1995SE |
| K946262 | Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional | Scott Imaging Intl., Inc. | 02/15/1995SE |
| K942916 | Octopaque UniversalIXQ · Traditional | Octostop, Inc. | 09/08/1994SE |
| K942190 | ID100 Mobile Fluoroscopic Examining TableIXQ · Traditional | Image Diagnostics, Inc. | 08/17/1994SE |
| K913425 | Dial-A-Rad Porta Rad TableIXQ · Traditional | Dial-A-Rad | 11/24/1992SE |
| K923775 | R-Made Head/Arm SupportIXQ · Traditional | R-Made, Inc. | 10/20/1992SE |
| K920729 | Bucky Table BK-12IXQ · Traditional | Shimadzu Medical Systems | 04/27/1992SE |
| K914351 | Clinitron C-10IXQ · Traditional | Ssi Medical Services, Inc. | 02/14/1992SE |
More from Ssi Medical Services, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K895969 | Radkor DXG-650RIZO · Traditional | 11/13/1989SE |
| 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 |
| 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 TS10-B cleared by the FDA?
Radkor TS10-B (K892196) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 23 days after the submission was received.
What is the product code of K892196?
The FDA product code is IXQ – Table, Radiographic, Stationary Top, a Class II (moderate risk) device regulated under 21 CFR 892.1980.