GenX-CR
FDA 510(k) K232158 · Genoray Co., Ltd.
510(k) numberK232158
Submission
- Device name
- GenX-CR
- Applicant
- Genoray Co., Ltd.
Seongnam-Si, KR - Received
- July 20, 2023
- Decision date
- September 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K243420 | HestiaMUE · Traditional | 07/17/2025SE |
| K232085 | Dvas (Dvas-M, Dvas-W)EHD · Traditional | 12/08/2023SE |
| K230787 | Oscar 15 & Oscar 15iOWB · Traditional | 07/20/2023SE |
| K220423 | PAPAYA & PAPAYA PlusMUH · Traditional | 05/19/2022SE |
| K220392 | PAPAYA 3D & PAPAYA 3D PlusOAS · Traditional | 05/19/2022SE |
| K211780 | ZEN-2090 TurboOWB · Traditional | 03/09/2022SE |
| K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium PlusOAS · Traditional | 09/16/2020SE |
| K181943 | OSCAR (OSCAR Prime, OSCAR Classic)OWB · Traditional | 08/17/2018SE |
Questions and answers
When was GenX-CR cleared by the FDA?
GenX-CR (K232158) received a 510(k) decision of Substantially Equivalent on September 13, 2023, 55 days after the submission was received.
What is the product code of K232158?
The FDA product code is MUH – System, X-Ray, Extraoral Source, Digital, a Class II (moderate risk) device regulated under 21 CFR 872.1800.