CAP-35B Iii/Cine 275
FDA 510(k) K971128 · Jamieson Film Co.
510(k) numberK971128
Submission
- Device name
- CAP-35B Iii/Cine 275
- Applicant
- Jamieson Film Co.
Dallas, TX, US - Received
- March 27, 1997
- Decision date
- April 28, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| 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 |
| K953556 | Vacs Table, 9650IXR · Traditional | U.S. Imaging Tables, Inc. | 09/26/1995SE |
More from U.S. Imaging Tables, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970738 | Kodak Digital Science Cardiac Digital Acquisition UnitIZI · Traditional | 05/07/1997SE |
| K963334 | Jamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100IXX · Traditional | 09/11/1996SE |
| K960043 | Kodak Cardiology Digital Archive & Review SystemLLZ · Traditional | 03/27/1996SE |
| K953563 | Vanguard XR-350 Cineangiogram ProjectorIZI · Traditional | 10/05/1995SE |
| K913241 | Jamieson Jt-Crp Cine Film ProcessorIXX · Traditional | 09/24/1991SE |
Questions and answers
When was CAP-35B Iii/Cine 275 cleared by the FDA?
CAP-35B Iii/Cine 275 (K971128) received a 510(k) decision of Substantially Equivalent on April 28, 1997, 32 days after the submission was received.
What is the product code of K971128?
The FDA product code is IXR – Table, Radiographic, Tilting, a Class II (moderate risk) device regulated under 21 CFR 892.1980.