TBX Medical X-Ray Table
FDA 510(k) K854459 · Gendex Corp.
510(k) numberK854459
Submission
- Device name
- TBX Medical X-Ray Table
- Applicant
- Gendex Corp.
Franklin Park, IL, US - Received
- November 6, 1985
- Decision date
- February 12, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964025 | Mitaya Aluminum Interspaced X-Ray GridIXJ · Traditional | X-Ray Accessory Corp. | 06/13/1997SE |
| K963893 | Fibre Interspaced X-Ray GridIXJ · Traditional | Smit Rontgen | 11/07/1996SE |
| K962338 | Radiographic GridIXJ · Traditional | Unidex Group, Inc. | 07/03/1996SE |
| K954294 | High Transmission Cellular (HTC) Grids 18X24 CM & 24X30 CM SizesIXJ · Traditional | Thermotrex Corp. | 02/02/1996SE |
| K945697 | SK S-Ray GridsIXJ · Traditional | Seibu Techno Coproration | 01/31/1995SE |
| K945327 | Jpi X-Ray GridIXJ · Traditional | Jpi America, Inc. | 01/20/1995SE |
| K941626 | GridgilIXJ · Traditional | Gilardoni S.P.A. | 05/13/1994SE |
| K940309 | X-Ray Grid (Radiological Grid)IXJ · Traditional | J.P.I. Chicago Co. | 04/22/1994SE |
| K926445 | Soyee Aluminum Interspaced X-Ray GridIXJ · Traditional | X-Ray Accessories Mfg. Co. | 04/07/1993SE |
| K926261 | Jpi Aluminum Interspaced X-Ray GridIXJ · Traditional | Jpi, Inc. | 03/18/1993SE |
More from Jpi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K952598 | Gx-Pan Panoramic Dental X-Ray SystemGEX · Traditional | 06/29/1995SE |
| K945682 | Processor, Radiographic-Film, Automatic, DentalEGY · Traditional | 02/09/1995SE |
| K935046 | GX-770 X-Ray Control, Model 46-404600G4EHD · Traditional | 02/18/1994SE |
| K925094 | Visualix Radiographic Image Detecting and ProcessEHD · Traditional | 09/29/1993SE |
| K931001 | Oralix DCEHD · Traditional | 09/14/1993SE |
| K932675 | GXP Dental X-Ray ProcessorEGN · Traditional | 07/26/1993SE |
| K922165 | ATC725, ATC525, and AP300IZO · Traditional | 07/27/1992SE |
| K920189 | Gx-C CephalometerEAG · Traditional | 04/28/1992SE |
| K894188 | Gx-ElevatorIZZ · Traditional | 10/03/1989SE |
| K890083 | GX-2000 Stationary X-Ray GeneratorIZO · Traditional | 03/31/1989SE |
Questions and answers
When was TBX Medical X-Ray Table cleared by the FDA?
TBX Medical X-Ray Table (K854459) received a 510(k) decision of Substantially Equivalent on February 12, 1986, 98 days after the submission was received.
What is the product code of K854459?
The FDA product code is IXJ – Grid, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1910.