MD Auto Segmentation for Smart Subscription

MD Auto Segmentation for Smart Subscription
Auto Segmentation - 1.0

An application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.

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: 00195278560384

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