GXP Dental X-Ray Processor
FDA 510(k) K932675 · Gendex Corp.
510(k) numberK932675
Submission
- Device name
- GXP Dental X-Ray Processor
- Applicant
- Gendex Corp.
Des Plaines, IL, US - Received
- June 2, 1993
- Decision date
- July 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851720 | 1155/1 to 1162/12 Various Types Gum ScissorsEGN · Traditional | Artiberia | 07/02/1985SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821276 | Mayo Scissor Curyed 5 1/2EGN · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821275 | Mayo Scissor Straight 5 1/2EGN · Traditional | Conphar, Inc. | 05/28/1982SE |
| K821077 | ConpharEGN · Traditional | Conphar, Inc. | 05/24/1982SE |
More from Conphar, 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 |
| 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 |
| K873982 | Gx-Mobile X-Ray UnitIZL · Traditional | 10/30/1987SE |
Questions and answers
When was GXP Dental X-Ray Processor cleared by the FDA?
GXP Dental X-Ray Processor (K932675) received a 510(k) decision of Substantially Equivalent on July 26, 1993, 54 days after the submission was received.
What is the product code of K932675?
The FDA product code is EGN – Scissors, Surgical Tissue, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.