Drystar 5300 Medical Image Printer, Model 5300
FDA 510(k) K032635 · Agfa Corp.
510(k) numberK032635
Submission
- Device name
- Drystar 5300 Medical Image Printer, Model 5300
- Applicant
- Agfa Corp.
Greenville, SC, US - Received
- August 26, 2003
- Decision date
- September 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Drystar 5300 Medical Image Printer, Model 5300 cleared by the FDA?
Drystar 5300 Medical Image Printer, Model 5300 (K032635) received a 510(k) decision of Substantially Equivalent on September 24, 2003, 29 days after the submission was received.
What is the product code of K032635?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.