Software version
Affiniti 70 Diagnostic Ultrasound System - 795210
Device Description
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.
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: 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 IdentifiersDevice Id: 00884838114180
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