Imation SE-196 Laser Imager
FDA 510(k) K972163 · Imation Corp.
510(k) numberK972163
Submission
- Device name
- Imation SE-196 Laser Imager
- Applicant
- Imation Corp.
Oakdale, MN, US - Received
- June 9, 1997
- Decision date
- September 5, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Imation SE-196 Laser Imager cleared by the FDA?
Imation SE-196 Laser Imager (K972163) received a 510(k) decision of Substantially Equivalent on September 5, 1997, 88 days after the submission was received.
What is the product code of K972163?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.