Phased array probe D6P64L

by CHISON Medical Technologies Co., Ltd.

Phased array probe D6P64L 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 24 Sep 2016 (UDI-DI 06945121400251), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06945121400251 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK153085	Date21 Dec 2015Decided	StatusActive

Official records

AccessGUDID record UDI-DI 06945121400251
FDA 510(k) database 510(k) number K153085

Across registries

2 registries list this device

FDA 510(k) K153085 decided 21 Dec 2015 Active
FDA GUDID UDI-DI 06945121400251 listed 24 Sep 2016 Listed

Timeline

2 dated events

21 Dec 2015 Cleared FDA 510(k) K153085
24 Sep 2016 Listed FDA GUDID 06945121400251

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Phased array probe
Generic name: Foetal Doppler system probe
Model / reference: D6P64L

Primary DI / UDI-DI: 06945121400251
510(k) Number: K153085
FDA product code: ITX
GMDN term: Foetal Doppler system probe

Device class: Class II
Regulation number: 892.1570
GUDID distribution status: In Commercial Distribution

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)