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FDA 510(k)

syngo.CT Brain Hemorrhage

K-Number: K232431 · 2024-03-22

Decision Date2024-03-22
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

syngo.CT Brain Hemorrhage is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2024-03-22 under approval number K232431. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the syngo.CT Brain Hemorrhage?

syngo.CT Brain Hemorrhage is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K232431.

When was syngo.CT Brain Hemorrhage approved by the FDA?

syngo.CT Brain Hemorrhage received FDA 510(k) clearance on 2024-03-22, under approval number K232431.

What company makes syngo.CT Brain Hemorrhage?

syngo.CT Brain Hemorrhage is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for syngo.CT Brain Hemorrhage?

The FDA product code for syngo.CT Brain Hemorrhage is QAS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.