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Preirus HITACHI5.1UPGRD

by PENTAX of America Inc.

Preirus HITACHI5.1UPGRD is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K093466 on 17 Jun 2010 and listed in FDA GUDID since 12 Mar 2018 (UDI-DI 04961333243105), active as of 8 Nov 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 ongoing

1 closed

Documents

510(k) K093466

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333243105 UDI-DI Date12 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK093466 Date17 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093466 decided 17 Jun 2010 Active
  • FDA GUDID UDI-DI 04961333243105 listed 12 Mar 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-2467-2011 FDA Unclassified (pre-2012) initiated 18 Apr 2011 on shared 510(k) K093466

    Software anomaly. The Doppler Trace Measurement feature on certain models of the firm's diagnostic ultrasound systems, may, under certain conditions whereby multiple measurements are done sequentially, record incorrect values. The recorded value is displayed to the user on a report; however depending upon the measurement area, displayed velocity values could be lower than at the true velocity lead

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K093466
  2. Recall initiated FDA recalls Z-2467-2011
  3. Listed FDA GUDID 04961333243105

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Preirus
Generic name
General-purpose ultrasound imaging system
Model / reference
HITACHI5.1UPGRD
Primary DI / UDI-DI
04961333243105
510(k) Number
FDA product code
IYO
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose ultrasound imaging system

Cleared under the same submission (K093466)

and 4 more cleared under K093466

Similar devices in this category

Other devices filed under General-purpose ultrasound imaging system.

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)