Skip to content

Convex probe D5C40L

by CHISON Medical Technologies Co., Ltd.

Convex probe D5C40L is a Class II device made by CHISON Medical Technologies Co., Ltd., cleared under FDA 510(k) K153085 on 21 Dec 2015 and listed in FDA GUDID since 28 Sep 2016 (UDI-DI 06945121400114), 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) K153085

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 Number06945121400114 UDI-DI Date28 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153085 Date21 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153085 decided 21 Dec 2015 Active
  • FDA GUDID UDI-DI 06945121400114 listed 28 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153085
  2. Listed FDA GUDID 06945121400114

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Convex probe
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
D5C40L
Primary DI / UDI-DI
06945121400114
510(k) Number
FDA product code
ITX
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Extracorporeal ultrasound imaging transducer, hand-held.

Other devices from CHISON Medical Technologies Co., Ltd.

See all devices from CHISON Medical Technologies Co., Ltd. →

Properties

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