Visualix Radiographic Image Detecting and Process
FDA 510(k) K925094 · Gendex Corp.
510(k) numberK925094
Submission
- Device name
- Visualix Radiographic Image Detecting and Process
- Applicant
- Gendex Corp.
Des Plaines, IL, US - Received
- October 7, 1992
- Decision date
- September 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Visualix Radiographic Image Detecting and Process cleared by the FDA?
Visualix Radiographic Image Detecting and Process (K925094) received a 510(k) decision of Substantially Equivalent on September 29, 1993, 357 days after the submission was received.
What is the product code of K925094?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.