Venue

Venue - 40 BT11 to BT12 UPG with KMST

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

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
30.00

Handling Environment Temperature - Degrees Celsius

40.00
10.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

50.00
-5.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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: 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

Device Identifiers

Device Id: 00840682119849

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