Radiology · 510(k) · 2021
Saige-Q
DeepHealth, Inc.. Cleared by FDA on 16 April 2021 under submission K203517, product code QFM (radiological computer-assisted prioritization software for lesions). What FDA's record says, in FDA's words.
Device record · K203517
- Device. Saige-QDEVICE
- Company. DeepHealth, Inc.COMPANY
- Decision. 16 April 2021, 510(k), substantially equivalent (traditional review); received 30 November 2020DECISION
- Panel. RadiologyPANEL
- Product code. QFM, Radiological Computer-Assisted Prioritization Software For LesionsCODE
- Regulation. 21 CFR 892.2080, Class IIREG
- Source. FDA database entry · decision document (9 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.
Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms. Saige-Q uses an artificial intelligence algorithm to generate a code for a given mammogram, indicative of the software’s suspicion that the mammogram contains at least one suspicious finding. Saige-Q makes the assigned codes available to a PACS/EPR/RIS/workstation for worklist prioritization or triage. Saige-Q is intended for passive notification only and does not provide any diagnostic information beyond triage and prioritization. Thus, it is not intended to replace the review of images or be used on a stand-alone basis for clinical decision-making. The decision to use Saige-Q codes and how to use those codes is ultimately up to the interpreting radiologist. The interpreting radiologist is responsible for reviewing each exam on a diagnostic viewer and evaluating each patient according to the current standard of care. Summary of Technological Characteristics Saige-Q is a software only device that consists of several core components that perform the following functions: 1) receive mammogram study data as DICOM files, 2) preprocess the DICOM files and check that the study is appropriate for analysis, 3) analyze the study images using an artificial intelligence algorithm, 4) generate outputs based on the analysis and 5) send the outputs […]
The product code's definition, from FDA's classification record. Radiological computer-assisted prioritization software for lesions 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.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QFM. 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 QFM, in Radiology, from DeepHealth, Inc., or cleared in 2021. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.