Scanaray/Cd-Dent Advanced Computerized X-Ray System
FDA 510(k) K974619 · Afp Imaging Corp.
510(k) numberK974619
Submission
- Device name
- Scanaray/Cd-Dent Advanced Computerized X-Ray System
- Applicant
- Afp Imaging Corp.
North Attleboro, MA, US - Received
- December 11, 1997
- Decision date
- February 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Scanaray/Cd-Dent Advanced Computerized X-Ray System cleared by the FDA?
Scanaray/Cd-Dent Advanced Computerized X-Ray System (K974619) received a 510(k) decision of Substantially Equivalent on February 25, 1998, 76 days after the submission was received.
What is the product code of K974619?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.