Mianyang Meike Electronic Equipment Co., Ltd.

Address:No.63, Yinping Road, Longmen Town, Fucheng District,Mianyang Sichuan,CN

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Imaging, Pulsed Echo, Ultrasonic (IYO) (3) Transducer, Ultrasonic, Diagnostic (ITX) (3)

Premarket Exempt

Clear

Bladder Scanner - 06940912714012 Catalog Number :

Device Description : PBS V4.1 Bladder Scanner is a medical device with high performance combined with PBS V4.1 Bladder Scanner is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.It is intended to project ultrasound energy through thle lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image tocalculate the bladder volume non-invasively. It is contraindlicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wotund and skin disease.

Device Class : 2

Duns Number: 529177985

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

Bladder Scanner - 06940912715019 Catalog Number :

Device Description : Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combine Palm Bladder Scanner - PBSV5.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The device consists of host and probe, it can speedily complete the detection of bladder area through scan of probe connected with the device, and transmit B ultrasound echo signal detected to embedded computer system after processing before computer identifies the edge of image and volume calculation, realizes the measurement of bladder volume, displays and prints out the relative information through LED/built-in printer.

Device Class : 2

Duns Number: 529177985

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

Palm Bladder Scanner - 06940912716016 Catalog Number :

Device Description : Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combine Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.

Device Class : 2

Duns Number: 529177985

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

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