Gx-Mobile X-Ray Unit
FDA 510(k) K873982 · Gendex Corp.
510(k) numberK873982
Submission
- Device name
- Gx-Mobile X-Ray Unit
- Applicant
- Gendex Corp.
Franklin Park, IL, US - Received
- September 30, 1987
- Decision date
- October 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
More from H&abyz Co., Ltd.
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|---|---|---|
| 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 Gx-Mobile X-Ray Unit cleared by the FDA?
Gx-Mobile X-Ray Unit (K873982) received a 510(k) decision of Substantially Equivalent on October 30, 1987, 30 days after the submission was received.
What is the product code of K873982?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.