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Volume probe VE6-T

by CHISON Medical Technologies Co., Ltd.

Volume probe VE6-T is a Class II device made by CHISON Medical Technologies Co., Ltd., cleared under FDA 510(k) K200780 on 5 Aug 2020 and listed in FDA GUDID since 10 Feb 2022 (UDI-DI 06945121413534), 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) K200780

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 Number06945121413534 UDI-DI Date10 Feb 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200780 Date5 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200780 decided 5 Aug 2020 Active
  • FDA GUDID UDI-DI 06945121413534 listed 10 Feb 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200780
  2. Listed FDA GUDID 06945121413534

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Volume probe
Generic name
Rectal/vaginal ultrasound imaging transducer
Model / reference
VE6-T
Primary DI / UDI-DI
06945121413534
510(k) Number
FDA product code
ITX
GMDN term
Rectal/vaginal ultrasound imaging transducer
Device class
Class II
Regulation number
892.1570
GUDID distribution status
In Commercial Distribution

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Other devices filed under Rectal/vaginal ultrasound imaging transducer.

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)