AI
AI-Rad Companion Prostate MR - 11294432
Device Description
A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 04056869257952
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
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