Interad 520
FDA 510(k) K833821 · Interad Systems, Inc.
510(k) numberK833821
Submission
- Device name
- Interad 520
- Applicant
- Interad Systems, Inc.
Mchenry, IL, US - Received
- November 2, 1983
- Decision date
- January 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Interad 520 cleared by the FDA?
Interad 520 (K833821) received a 510(k) decision of Substantially Equivalent on January 13, 1984, 72 days after the submission was received.
What is the product code of K833821?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.