OX-600
FDA 510(k) K920196 · Stardard X-Ray Sales Co.
510(k) numberK920196
Submission
- Device name
- OX-600
- Applicant
- Stardard X-Ray Sales Co.
Irvington, NJ, US - Received
- January 15, 1992
- Decision date
- October 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KPX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945635 | Trans X-1000KPX · Traditional | Canon USA, Inc. | 02/01/1995SE |
| K935157 | Articulated, Laparoscopic, and Side-Viewing T-ProbesKPX · Traditional | Regulatory Consultants TO the Medical Device Indus | 08/09/1994SE |
| K934850 | Nuclear Associates Personnel Protective ShieldsKPX · Traditional | Victoreen, Inc. | 11/22/1993SE |
| K933035 | BCM-600TXKPX · Traditional | B C Medical , Ltd. | 10/08/1993SE |
| K925598 | Buckymatic Automatic Chest Film ChangerKPX · Traditional | Acoma Medical Imaging, Inc. | 02/01/1993SE |
| K924423 | MWX-7440 High Speed BuckyKPX · Traditional | Midwest X-Ray Equipment Co. | 01/15/1993SE |
| K925169 | Shimadzu Radiograpjhic Stand BR-100KPX · Traditional | Shimadzu Medical Systems | 12/03/1992SE |
| K922483 | Du Pont Compact Daylight System 2000KPX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/11/1992SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | Mallinckrodt Group, Inc. | 05/20/1991SE |
| K902761 | Automatic Cassette LoaderKPX · Traditional | Mallinckrodt Group, Inc. | 10/09/1990SE |
Questions and answers
When was OX-600 cleared by the FDA?
OX-600 (K920196) received a 510(k) decision of Substantially Equivalent on October 14, 1992, 273 days after the submission was received.
What is the product code of K920196?
The FDA product code is KPX – Changer, Radiographic Film/Cassette, a Class II (moderate risk) device regulated under 21 CFR 892.1860.