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FDA 510(k)

Scaida BrainCT-ICH (v1.0)

K-Number: K250694 · 2025-11-25

ApplicantMlhealth 360
Decision Date2025-11-25
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Scaida BrainCT-ICH (v1.0) is a medical device manufactured by Mlhealth 360. It received FDA 510(k) clearance on 2025-11-25 under approval number K250694. 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 Scaida BrainCT-ICH (v1.0)?

Scaida BrainCT-ICH (v1.0) is a medical device that received FDA 510(k) clearance on 2025-11-25. It is manufactured by Mlhealth 360. The 510(k) number is K250694.

When was Scaida BrainCT-ICH (v1.0) approved by the FDA?

Scaida BrainCT-ICH (v1.0) received FDA 510(k) clearance on 2025-11-25, under approval number K250694.

What company makes Scaida BrainCT-ICH (v1.0)?

Scaida BrainCT-ICH (v1.0) is manufactured by Mlhealth 360.

What is the FDA product code for Scaida BrainCT-ICH (v1.0)?

The FDA product code for Scaida BrainCT-ICH (v1.0) is QAS.

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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.

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