3M Digital Recording Automatic Film Handling Unit
FDA 510(k) K912225 · 3M Medical Products Group
510(k) numberK912225
Submission
- Device name
- 3M Digital Recording Automatic Film Handling Unit
- Applicant
- 3M Medical Products Group
St Paul, MN, US - Received
- May 20, 1991
- Decision date
- July 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was 3M Digital Recording Automatic Film Handling Unit cleared by the FDA?
3M Digital Recording Automatic Film Handling Unit (K912225) received a 510(k) decision of Substantially Equivalent on July 22, 1991, 63 days after the submission was received.
What is the product code of K912225?
The FDA product code is IXW – Processor, Radiographic-Film, Automatic, a Class II (moderate risk) device regulated under 21 CFR 892.1900.