Bladder Scanner M2

• FDA 510(k) K190769 decided 22 May 2019 Active
• FDA GUDID UDI-DI 06975124100193 listed 1 Apr 2023 Listed

1. 22 May 2019 Cleared FDA 510(k) K190769
2. 1 Apr 2023 Listed FDA GUDID 06975124100193

Trade name

Bladder Scanner

Generic name

Bladder volume ultrasound imaging system

Model / reference

M2

Primary DI / UDI-DI

06975124100193

510(k) Number

K190769 ↗

FDA product code

ITX, IYO

GMDN term

Bladder volume ultrasound imaging system

Device class

Class II

Regulation number

892.1570, 892.1560

GUDID distribution status

In Commercial Distribution

Category: Bladder volume ultrasound imaging system

Other devices filed under FDA product code ITX (Transducer, Ultrasonic, Diagnostic).

• V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER by SIEMENS MEDICAL SOLUTIONS USA, INC.
• CIV-Flex™ Transducer Cover 610-1391 by CIVCO MEDICAL INSTRUMENTS CO., INC.
• Multi-Dop T digital MDT R13 CO2 8001 by Compumedics Germany Gmgh
• ML6-15-D by GE HEALTHCARE JAPAN CORPORATION
• 11M3 Transducer 11284923 by SIEMENS MEDICAL SOLUTIONS USA, INC.
• ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM by CIVCO MEDICAL INSTRUMENTS CO., INC.
• Medistim Vascular TTFM probe PV100031 by Medistim ASA
• Convex Probe C5-2 A7C9 by KONICA MINOLTA, INC.
• Non-implantable, needle guide, reusable UA1328 by Bk Medical ApS
• UNBRANDED 20-PC624 by Advance Medical Designs, Inc.

• Bladder Scanner M1

  Class II

  FDA 510(k) K190769 Active Cleared 22 May 2019 GUDID on market

• Bladder Scanner M4

  Class II

  FDA 510(k) K201316 Active Cleared 26 Feb 2021 GUDID on market

• Bladder Scanner M2

  Class II

  FDA 510(k) K190769 Active Cleared 22 May 2019 GUDID on market

• Bladder Scanner M3

  Class II

  FDA 510(k) K201316 Active Cleared 26 Feb 2021 GUDID on market

See all devices from Suzhou PeakSonic Medical Technology Co., LTD. →