3M Laser Imager XL
FDA 510(k) K910092 · 3M Medical Products Group
510(k) numberK910092
Submission
- Device name
- 3M Laser Imager XL
- Applicant
- 3M Medical Products Group
St Paul, MN, US - Received
- January 9, 1991
- Decision date
- April 8, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 3M Laser Imager XL cleared by the FDA?
3M Laser Imager XL (K910092) received a 510(k) decision of Substantially Equivalent on April 8, 1991, 89 days after the submission was received.
What is the product code of K910092?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.