Critical Care Suite 2.0, Designated Medical Device

Critical Care Suite 2.0, Designated Medical Device
Critical Care Suite - 2.0

An interpretive software program intended to be used to analyse non-dental x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QFM

Device Name: Radiological Computer-Assisted Prioritization Software For Lesions

Device Class: 2

Physical State: The device is software only.

Definition: 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.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device provides triage or notification that is informed by machine learning, artificial intelligence or other image analysis algorithms.This type of device establishes effective triage within a specialists queue based on high sensitivity and specificity >95% AUC.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The device operates on radiological images of the human body.

Regulation Number: 892.2080

Third Party Flag: N

Medical Specialty: RA

Device Id: 00195278217981

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A