GX-770 X-Ray Control, Model 46-404600G4
FDA 510(k) K935046 · Gendex Corp.
510(k) numberK935046
Submission
- Device name
- GX-770 X-Ray Control, Model 46-404600G4
- Applicant
- Gendex Corp.
Des Plaines, IL, US - Received
- October 20, 1993
- Decision date
- February 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
| K873982 | Gx-Mobile X-Ray UnitIZL · Traditional | 10/30/1987SE |
Questions and answers
When was GX-770 X-Ray Control, Model 46-404600G4 cleared by the FDA?
GX-770 X-Ray Control, Model 46-404600G4 (K935046) received a 510(k) decision of Substantially Equivalent on February 18, 1994, 121 days after the submission was received.
What is the product code of K935046?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.