Compact Laser Imager, Model CLI-100
FDA 510(k) K902347 · Lumisys, Inc.
510(k) numberK902347
Submission
- Device name
- Compact Laser Imager, Model CLI-100
- Applicant
- Lumisys, Inc.
San Leandro, CA, US - Received
- May 25, 1990
- Decision date
- March 4, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Compact Laser Imager, Model CLI-100 cleared by the FDA?
Compact Laser Imager, Model CLI-100 (K902347) received a 510(k) decision of Substantially Equivalent on March 4, 1991, 283 days after the submission was received.
What is the product code of K902347?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.