Surgical C-Arm Table, 9610
FDA 510(k) K953557 · U.S. Imaging Tables, Inc.
510(k) numberK953557
Submission
- Device name
- Surgical C-Arm Table, 9610
- Applicant
- U.S. Imaging Tables, Inc.
Northport, NY, US - Received
- July 17, 1995
- Decision date
- September 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K953556 | Vacs Table, 9650IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
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Questions and answers
When was Surgical C-Arm Table, 9610 cleared by the FDA?
Surgical C-Arm Table, 9610 (K953557) received a 510(k) decision of Substantially Equivalent on September 26, 1995, 71 days after the submission was received.
What is the product code of K953557?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.