Radiology · 510(k) · 2025
Scaida BrainCT-ICH (v1.0)
Mlhealth 360. Cleared by FDA on 25 November 2025 under submission K250694, product code QAS (radiological computer-assisted triage and notification software). What FDA's record says, in FDA's words.
Device record · K250694
- Device. Scaida BrainCT-ICH (v1.0)DEVICE
- Company. Mlhealth 360 (CA)COMPANY
- Decision. 25 November 2025, 510(k), substantially equivalent (traditional review); received 7 March 2025DECISION
- Panel. RadiologyPANEL
- Product code. QAS, Radiological Computer-Assisted Triage And Notification SoftwareCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, and the overall performance from the subject device does not have significant differences as the predicate device. Both devi ces leverage artificial intelligence algorithms to identify ICH findings from non -contrast brain CT scans, and notify the radiologists to assist them in triage of medical images. Both devices are also intended to be used in conjunction with the clinician’s professional judgement. Results presented with this submission demonstrate that the Scaida BrainCT -ICH device is as safe and effective as the legally marketed predicate device InferRead CT Stroke.AI (K211179), as per the comparison table below. Item Scaida BrainCT-ICH (Subject device) InferRead CT Stroke.AI K211179 (Predicate device)
The product code's definition, from FDA's classification record. Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionstriage or notification
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QAS. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QAS, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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