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Caresono HD5

by Caresono Technology Co., Ltd.

Caresono HD5 is a Class II device made by Caresono Technology Co., Ltd., cleared under FDA 510(k) K131227 on 12 Jul 2013 and listed in FDA GUDID since 4 Feb 2025 (UDI-DI 16971003430013), active as of 23 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 23 Oct 2026

Documents

510(k) K131227

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16971003430013 UDI-DI Date4 Feb 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK131227 Date12 Jul 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K131227 decided 12 Jul 2013 Active
  • FDA GUDID UDI-DI 16971003430013 listed 4 Feb 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K131227
  2. Listed FDA GUDID 16971003430013

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Caresono
Generic name
Bladder volume ultrasound imaging system
Model / reference
HD5
Primary DI / UDI-DI
16971003430013
510(k) Number
FDA product code
IYO, ITX
GMDN term
Bladder volume ultrasound imaging system
Device class
Class II
Regulation number
892.1560, 892.1570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bladder volume ultrasound imaging system

Cleared under the same submission (K131227)

Similar devices

Other devices filed under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic).

Other devices from Caresono Technology Co., Ltd.

  • Caresono HD2

    Class II

  • Caresono HD3

    Class II

  • Bladder Scanner

    Class II

Properties

  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)