AI-Rad Companion Organs RT

AI-Rad Companion Organs RT - 11665278

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).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: QKB

Device Name: Radiological Image Processing Software For Radiation Therapy

Device Class: 2

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

Definition: To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning 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 (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning 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: 04056869955667

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