Medrad Image Management System (Mims)
FDA 510(k) K883604 · Medrad, Inc.
510(k) numberK883604
Submission
- Device name
- Medrad Image Management System (Mims)
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- August 24, 1988
- Decision date
- November 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Medrad Image Management System (Mims) cleared by the FDA?
Medrad Image Management System (Mims) (K883604) received a 510(k) decision of Substantially Equivalent on November 15, 1988, 83 days after the submission was received.
What is the product code of K883604?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.