IntelePACS
K-Number: K192176 · 2020-04-02
Decision Date2020-04-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
IntelePACS is a medical device manufactured by Intelerad Medical Systems Incorporated. It received FDA 510(k) clearance on 2020-04-02 under approval number K192176. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IntelePACS?
IntelePACS is a medical device that received FDA 510(k) clearance on 2020-04-02. It is manufactured by Intelerad Medical Systems Incorporated. The 510(k) number is K192176.
When was IntelePACS approved by the FDA?
IntelePACS received FDA 510(k) clearance on 2020-04-02, under approval number K192176.
What company makes IntelePACS?
IntelePACS is manufactured by Intelerad Medical Systems Incorporated.
What is the FDA product code for IntelePACS?
The FDA product code for IntelePACS is LLZ.
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.