Medex X-Ray Table
FDA 510(k) K854328 · Philips Medical Systems (Cleveland), Inc.
510(k) numberK854328
Submission
- Device name
- Medex X-Ray Table
- Applicant
- Philips Medical Systems (Cleveland), Inc.
Highland Heights, OH, US - Received
- October 28, 1985
- Decision date
- January 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
| K931724 | Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional | Continental X-Ray Corp. | 06/14/1993SE |
| 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 |
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Questions and answers
When was Medex X-Ray Table cleared by the FDA?
Medex X-Ray Table (K854328) received a 510(k) decision of Substantially Equivalent on January 28, 1986, 92 days after the submission was received.
What is the product code of K854328?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.