Electrophysiology (Ep) Table Ep 2000 Series
FDA 510(k) K931724 · Continental X-Ray Corp.
510(k) numberK931724
Submission
- Device name
- Electrophysiology (Ep) Table Ep 2000 Series
- Applicant
- Continental X-Ray Corp.
Broadview, IL, US - Received
- March 24, 1993
- Decision date
- June 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050190 | ApolloKXJ · Abbreviated | Villa Sistemi Medicali S.P.A. | 03/25/2005SE |
| K963905 | Radiographic Itt TableKXJ · Traditional | X-Ray Technologies, Inc. | 11/12/1996SE |
| K955414 | XRT 400KXJ · Traditional | Wuestec Medical, Inc. | 07/24/1996SE |
| K951146 | Imaging TableKXJ · Traditional | Septa Corp. | 05/04/1995SE |
| K950068 | Carbon Fiber Couch InsertKXJ · Traditional | Medtec, Inc. | 04/06/1995SE |
| K950442 | Infrared Exposure Hand SwitchKXJ · Traditional | Medical X-Ray Intl., Inc. | 03/31/1995SE |
| K940696 | Syncra Tilt Option for Angio Diagnost 5KXJ · Traditional | Philips Medical Systems North America, Inc. | 03/16/1994SE |
| K926407 | Model Cole TAB-2 Table W/Model Cole SFD-2 SpotfilmKXJ · Traditional | Nucletron-Oldelft Corp. | 03/31/1993SE |
| K922098 | CAG-02AKXJ · Traditional | Toshiba America Medical Systems, In.C | 07/27/1992SE |
| K913121 | Omniflex Overhead Tubecrane CAT.#S-9108/#6713.400KXJ · Traditional | Continental X-Ray Corp. | 08/16/1991SE |
More from Continental X-Ray Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K972442 | Ceiling Mounted Lateral Positioner, Model No. 6896.002JAA · Traditional | 09/11/1997SE |
| K962140 | ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning…JAA · Traditional | 07/25/1996SE |
| K961690 | Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105JAA · Traditional | 06/27/1996SE |
| K954581 | Arc SeriesIZI · Traditional | 12/21/1995SE |
| K950571 | Linear FR Tomographic System: 0MT 8000, Model No. 6681.270IZF · Traditional | 03/31/1995SE |
| K942175 | Linear Tomographic System: PMT 6000IZF · Traditional | 08/17/1994SE |
| K942100 | Model TM Ep High Voltage GeneratorIZO · Traditional | 06/07/1994SE |
| K934686 | Molybdenum/Rhodium FiltersIZO · Traditional | 05/26/1994SE |
| K925934 | Wall Bucky Holders Lt. & Rt. Hand, & Center MountIXY · Traditional | 03/04/1993SE |
| K921986 | Patient Information Manager (Pim)IZH · Traditional | 10/16/1992SE |
Questions and answers
When was Electrophysiology (Ep) Table Ep 2000 Series cleared by the FDA?
Electrophysiology (Ep) Table Ep 2000 Series (K931724) received a 510(k) decision of Substantially Equivalent on June 14, 1993, 82 days after the submission was received.
What is the product code of K931724?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.