Critical Care Suite 2.1, Designated Medical Device

Critical Care Suite 2.1, Designated Medical Device
Critical Care Suite - 2.1

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: QBS

Device Name: Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Device Class: 2

Physical State: Software device that receives radiological images as an input and provides a concurrent read for presence or absence of fracture (detection and diagnosis) as an output

Definition: A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Analyzes radiological images using machine learning algorithms to detect and diagnose fracture.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Radiological images of anatomical sites that main contain fracture.

Regulation Number: 892.2090

Third Party Flag: N

Medical Specialty: RA

Code: QIH

Device Name: Automated Radiological Image Processing Software

Device Class: 2

Physical State: Software application and/or firmware, system components and accessories

Definition: To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human-derived imaging products

Regulation Number: 892.2050

Third Party Flag: N

Medical Specialty: RA

Device Id: 00195278789365

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