Software version - 10.0.X

Software version
Affiniti 30 Diagnostic Ultrasound System - 795218

A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: IYN

Device Name: System, Imaging, Pulsed Doppler, Ultrasonic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1550

Third Party Flag: Y

Medical Specialty: RA

Code: IYO

Device Name: System, Imaging, Pulsed Echo, Ultrasonic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1560

Third Party Flag: Y

Medical Specialty: RA

Code: ITX

Device Name: Transducer, Ultrasonic, Diagnostic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1570

Third Party Flag: Y

Medical Specialty: RA

Code: OBJ

Device Name: Catheter, Ultrasound, Intravascular

Device Class: 2

Physical State: Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.

Definition: For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Catheter with ultrasound sensors that is used with an imaging system to display ultrasound image.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Cardiovascular anatomy and physiology.

Regulation Number: 870.1200

Third Party Flag: N

Medical Specialty: CV

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: 00884838114197

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