Model RS-3 Radiographic Stand
FDA 510(k) K861995 · Medicor USA , Ltd.
510(k) numberK861995
Submission
- Device name
- Model RS-3 Radiographic Stand
- Applicant
- Medicor USA , Ltd.
Columbus, OH, US - Received
- May 23, 1986
- Decision date
- June 19, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
|---|---|---|
| K861994 | Model RS-3I Radiographic/Fluroscopic X-Ray SystemKPR · Traditional | 07/18/1986SE |
| K860025 | Model MS-325 Radiographic X-Ray GeneratorKPR · Traditional | 05/07/1986SE |
| K850761 | Model Pcx/Emy 525A Microprocesssor Control X-Ray CBZN · Traditional | 09/19/1985SE |
| K851358 | Model Bion 2/TYPE 90 Room IonizerFRF · Traditional | 07/01/1985SE |
| K851094 | Model Bion 1/TYPE 1084T Car IonizerFRF · Traditional | 06/19/1985SE |
| K843335 | Floor Mounted X-Ray TubestandIYB · Traditional | 11/27/1984SE |
| K840227 | UROLIX-3 Urological TableIXR · Traditional | 03/23/1984SE |
| K840225 | C-Arm Ceiling Crane FT-2JAA · Traditional | 03/22/1984SE |
| K840226 | Motor Tilted Exam. Table UV-56IXR · Traditional | 03/16/1984SE |
| K823695 | CPM Metabolic MonitorBZL · Traditional | 01/14/1983SE |
Questions and answers
When was Model RS-3 Radiographic Stand cleared by the FDA?
Model RS-3 Radiographic Stand (K861995) received a 510(k) decision of Substantially Equivalent on June 19, 1986, 27 days after the submission was received.
What is the product code of K861995?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.