Radkor KOB-84
FDA 510(k) K881700 · Radkor, Inc.
510(k) numberK881700
Submission
- Device name
- Radkor KOB-84
- Applicant
- Radkor, Inc.
Irvine, CA, US - Received
- April 19, 1988
- Decision date
- September 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050190 | ApolloKXJ · Abbreviated | Villa Sistemi Medicali S.P.A. | 03/25/2005SE |
| K963905 | Radiographic Itt TableKXJ · Traditional | X-Ray Technologies, Inc. | 11/12/1996SE |
| K955414 | XRT 400KXJ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K951146 | Imaging TableKXJ · Traditional | Septa Corp. | 05/04/1995SE |
| K950068 | Carbon Fiber Couch InsertKXJ · Traditional | Medtec, Inc. | 04/06/1995SE |
| K950442 | Infrared Exposure Hand SwitchKXJ · Traditional | Medical X-Ray Intl., Inc. | 03/31/1995SE |
| K940696 | Syncra Tilt Option for Angio Diagnost 5KXJ · Traditional | Philips Medical Systems North America, Inc. | 03/16/1994SE |
| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | Continental X-Ray Corp. | 06/14/1993SE |
| K926407 | Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional | Nucletron-Oldelft Corp. | 03/31/1993SE |
| K922098 | CAG-02AKXJ · Traditional | Toshiba America Medical Systems, In.C | 07/27/1992SE |
More from Toshiba America Medical Systems, In.C
| 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 |
| K883081 | Radkor, XG-515IZO · 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 KOB-84 cleared by the FDA?
Radkor KOB-84 (K881700) received a 510(k) decision of Substantially Equivalent on September 2, 1988, 136 days after the submission was received.
What is the product code of K881700?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.