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Aloka UST-964P-5 Endovaginal Transducer

by Corometrics Medical Systems, Inc.

510(k) K905000

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905000 Date31 Jan 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HEM
Device Class
Class II
Regulation
21 CFR Part 884.2225
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aloka Ust-964p-5 Endovaginal Transducer is an ultrasonic imager designed to transmit and receive ultrasonic energy into and from a female patient by pulsed echoscopy. It is classified as an obstetric-gynecologic ultrasonic imager. The device is used in the field of obstetrics and gynecology. It operates by using ultrasonic energy to produce images. The device is an example of a medical device that uses ultrasonic technology.

The Aloka Ust-964p-5 Endovaginal Transducer is supplied with a product code of HEM and has a regulation number of 884.2225. It has been assigned a device class of 2 by the FDA. The device was cleared on January 31, 1991, with a decision description of Substantially Equivalent. The device is associated with the medical specialty of obstetrics and gynecology.

Other devices from Corometrics Medical Systems, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Aloka UST-964P-5 Endovaginal Transducer used for?

    The Aloka UST-964P-5 Endovaginal Transducer is used in the field of obstetrics and gynecology to produce images using ultrasonic energy.

  • How is the device supplied?

    The device is supplied with a product code of HEM and has a regulation number of 884.2225.

  • Is the Aloka UST-964P-5 Endovaginal Transducer a single-use or reusable device?

    The device data does not specify whether the Aloka UST-964P-5 Endovaginal Transducer is single-use or reusable, but it is designed for use in medical settings.

  • What is the device class of the Aloka UST-964P-5 Endovaginal Transducer?

    The device has been assigned a device class of 2 by the FDA.