Cobrascan CR-1 Filmless
FDA 510(k) K022810 · Radiographic Digital Imaging, Inc.
510(k) numberK022810
Submission
- Device name
- Cobrascan CR-1 Filmless
- Applicant
- Radiographic Digital Imaging, Inc.
Torrance, CA, US - Received
- August 23, 2002
- Decision date
- October 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Cobrascan CR-1 Filmless cleared by the FDA?
Cobrascan CR-1 Filmless (K022810) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 49 days after the submission was received.
What is the product code of K022810?
The FDA product code is LMA – Digitizer, Image, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2030.