Trauma Table II
FDA 510(k) K874114 · Xre Corp.
510(k) numberK874114
Submission
- Device name
- Trauma Table II
- Applicant
- Xre Corp.
Littleton, MA, US - Received
- October 9, 1987
- Decision date
- November 16, 1987
- 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 |
|---|---|---|
| K973744 | Unicath SP Bi-Plane (Model M269 & M289)JAA · Traditional | 12/29/1997SE |
| K961193 | Full Frame Zoom SystemJAA · Traditional | 06/17/1996SE |
| K960998 | Xre CollimatorIZW · Traditional | 04/03/1996SE |
| K945449 | Unicath Llu Angiographic SystemIZI · Traditional | 02/27/1995SE |
| K936002 | Cinemac QasIZI · Traditional | 09/09/1994SE |
| K933460 | DVFX, Model M256IZI · Traditional | 04/07/1994SE |
| K924828 | Bi-NIZI · Traditional | 12/17/1992SE |
| K923654 | Poly Diagnost CDXIZI · Traditional | 11/20/1992SE |
| K913685 | Unicath Ep.IZI · Traditional | 11/07/1991SE |
| K912416 | Angiographic or Fluoroscopic X-Ray SystemIZI · Traditional | 08/28/1991SE |
Questions and answers
When was Trauma Table II cleared by the FDA?
Trauma Table II (K874114) received a 510(k) decision of Substantially Equivalent on November 16, 1987, 38 days after the submission was received.
What is the product code of K874114?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.