Tangent IV
FDA 510(k) K912586 · Fischer Imaging Corp.
510(k) numberK912586
Submission
- Device name
- Tangent IV
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- June 12, 1991
- Decision date
- August 2, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
|---|---|---|
| K042095 | MammotestIZH · Traditional | 10/29/2004SE |
| K021113 | MammopathMWP · Traditional | 06/13/2002SE |
| K981414 | LC PositionerJAA · Traditional | 07/16/1998SE |
| K973400 | Mammotest Adapter DriverIZH · Traditional | 11/10/1997SE |
| K964806 | MD-1835IXL · Traditional | 03/04/1997SE |
| K961207 | Ep-X BiplaneJAA · Traditional | 08/20/1996SE |
| K961022 | Tangent Vi TableIXR · Traditional | 05/03/1996SE |
| K950291 | Digital 625HFIZO · Traditional | 03/23/1995SE |
| K945619 | Athena HFXIZH · Traditional | 03/23/1995SE |
| K944150 | Micro X-65 HFIZO · Traditional | 09/16/1994SE |
Questions and answers
When was Tangent IV cleared by the FDA?
Tangent IV (K912586) received a 510(k) decision of Substantially Equivalent on August 2, 1991, 51 days after the submission was received.
What is the product code of K912586?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.