Prestilix 1690
FDA 510(k) K843926 · Cgr Medical Corp.
510(k) numberK843926
Submission
- Device name
- Prestilix 1690
- Applicant
- Cgr Medical Corp.
Columbia, MD, US - Received
- October 27, 1984
- Decision date
- December 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K000412 | Vision R/F Tilting TableIXR · Traditional | Villa Sistemi Medicali S.P.A. | 04/24/2000SE |
| K973039 | Legacy/Legacy-D TableIXR · Traditional | GE Medical Systems | 10/16/1997SE |
| K971128 | CAP-35B Iii/Cine 275IXR · Traditional | Jamieson Film Co. | 04/28/1997SE |
| K970640 | Philips Easy DiagnostIXR · Traditional | Philips Medical Systems North America, Inc. | 03/21/1997SE |
| K965105 | Electrophysiology Tilt Table Model #9660IXR · Traditional | U.S. Imaging Tables, Inc. | 01/30/1997SE |
| K965096 | Fluoroview Series Fluoroscopic TablesIXR · Traditional | U.S. Imaging Tables, Inc. | 01/27/1997SE |
| K963851 | Tilting Radiographic Table (Remote)IXR · Traditional | Acoma Medical Imaging, Inc. | 01/23/1997SE |
| K961022 | Tangent Vi TableIXR · Traditional | Fischer Imaging Corp. | 05/03/1996SE |
| K954356 | Compax 90/15EIXR · Traditional | General Electric Co. | 10/07/1995SE |
| K953557 | Surgical C-Arm Table, 9610IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
More from U.S. Imaging Tables, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843235 | StenoscopJAA · Traditional | 11/08/1984SE |
| K843985 | Suspension 7 · Traditional | 11/05/1984SE |
| K841649 | Maximax - 4IZP · Traditional | 06/05/1984SE |
| K833223 | Sonel 3000AIYO · Traditional | 05/09/1984SE |
| K834306 | Phasix-High Frequency GeneratorITY · Traditional | 12/29/1983SE |
| K833941 | OrionIYE · Traditional | 12/29/1983SE |
| K833846 | Process 100 STIZO · Traditional | 12/16/1983SE |
| K837465 | Alcyon Rotational Cobalt Therapy · Traditional | 06/28/1983SE |
| K837412 | Saturne I Linear Accelerator · Traditional | 06/28/1983SE |
| K837336 | Verasun Radiation Therapy Simulation System · Traditional | 04/29/1983SE |
Questions and answers
When was Prestilix 1690 cleared by the FDA?
Prestilix 1690 (K843926) received a 510(k) decision of Substantially Equivalent on December 17, 1984, 51 days after the submission was received.
What is the product code of K843926?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.