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Linear Array Transducer Plu-805ST

by Canon Inc.

Linear Array Transducer Plu-805ST is a Class II device made by Canon Inc., cleared under FDA 510(k) K173962 on 20 Apr 2018 and listed in FDA GUDID since 1 Mar 2026 (UDI-DI 04987670102752), 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) K173962

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 Number04987670102752 UDI-DI Date1 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173962 Date20 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173962 decided 20 Apr 2018 Active
  • FDA GUDID UDI-DI 04987670102752 listed 1 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173962
  2. Listed FDA GUDID 04987670102752

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Linear Array Transducer
Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
PLU-805ST
Primary DI / UDI-DI
04987670102752
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

Related devices

Cleared under the same submission (K173962)

and 8 more cleared under K173962

Similar devices

Other devices filed under FDA product code ITX (Transducer, ultrasonic, diagnostic).

Other devices from Canon Inc.

See all devices from Canon Inc. →

Properties

  • Serial number
Other properties (14, all answered No)