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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 the device name listed in this FDA 510(k) record. The listed applicant is Mlhealth 360. It received FDA 510(k) clearance on 2025-11-25 under 510(k) 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. The listed applicant is Mlhealth 360. The 510(k) number is K250694.

When did Scaida BrainCT-ICH (v1.0) receive FDA 510(k) clearance?

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

Who is the listed applicant for Scaida BrainCT-ICH (v1.0)?

The FDA 510(k) record lists Mlhealth 360 as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: QAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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