Skip to content

Bladder Scanner M5

by Suzhou PeakSonic Medical Technology Co., LTD.

Bladder Scanner M5 is a Class II device made by Suzhou PeakSonic Medical Technology Co., LTD., cleared under FDA 510(k) K213488 on 1 Jul 2022 and listed in FDA GUDID since 19 Sep 2023 (UDI-DI 06975124100773), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K213488

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06975124100773 UDI-DI Date19 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213488 Date1 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213488 decided 1 Jul 2022 Active
  • FDA GUDID UDI-DI 06975124100773 listed 19 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213488
  2. Listed FDA GUDID 06975124100773

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bladder Scanner
Generic name
Bladder volume ultrasound imaging system
Model / reference
M5
Primary DI / UDI-DI
06975124100773
510(k) Number
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

Related devices

Category: Bladder volume ultrasound imaging system

Similar devices

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

Other devices from Suzhou PeakSonic Medical Technology Co., LTD.

  • Bladder Scanner M1

    Class II

  • Bladder Scanner M4

    Class II

  • Bladder Scanner M2

    Class II

  • Bladder Scanner M3

    Class II

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

Properties

  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)