Model RS-3I Radiographic/Fluroscopic X-Ray System
FDA 510(k) K861994 · Medicor USA , Ltd.
510(k) numberK861994
Submission
- Device name
- Model RS-3I Radiographic/Fluroscopic X-Ray System
- Applicant
- Medicor USA , Ltd.
Columbus, OH, US - Received
- May 23, 1986
- Decision date
- July 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K861995 | Model RS-3 Radiographic StandIYB · Traditional | 06/19/1986SE |
| 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-3I Radiographic/Fluroscopic X-Ray System cleared by the FDA?
Model RS-3I Radiographic/Fluroscopic X-Ray System (K861994) received a 510(k) decision of Substantially Equivalent on July 18, 1986, 56 days after the submission was received.
What is the product code of K861994?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.