Fuji Computed Radiograp HI-C654 DMS CRT Image Cons
FDA 510(k) K931002 · Fujifilm Medical System U.S.A., Inc.
510(k) numberK931002
Submission
- Device name
- Fuji Computed Radiograp HI-C654 DMS CRT Image Cons
- Applicant
- Fujifilm Medical System U.S.A., Inc.
Stamford, CT, US - Received
- February 26, 1993
- Decision date
- June 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Fuji Computed Radiograp HI-C654 DMS CRT Image Cons cleared by the FDA?
Fuji Computed Radiograp HI-C654 DMS CRT Image Cons (K931002) received a 510(k) decision of Substantially Equivalent on June 8, 1993, 102 days after the submission was received.
What is the product code of K931002?
The FDA product code is IXK – System, Imaging, X-Ray, Electrostatic, a Class II (moderate risk) device regulated under 21 CFR 892.1630.