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5.0 MHZ LINEAR ARRAY - 83

by Siemens Medical Solutions USA, Inc.

510(k) K852570

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK852570 Date19 Sep 1985ClearedStatusActive

Official records

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  • Withdrawn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
IYO
Models / Variants
83
Device class
Class II
Regulation
21 CFR Part 892.1560
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a System, Imaging, Pulsed Echo, Ultrasonic transducer, classified under the Radiology specialty. It operates at a frequency of 5.0 MHz and is designed as a linear array probe for ultrasound imaging, enabling high-resolution visualization of superficial structures and soft tissues.

The 5.0 MHz Linear Array, Model 83, 39, 517 is intended for use with ultrasound imaging systems in clinical radiology settings. It is a reusable device, supplied sterile or non-sterile depending on manufacturer guidelines, and must comply with MRI safety standards as specified by the manufacturer. Authorized under FDA 510K clearance (K852570), this model was reviewed by the Radiology (RA) Advisory Committee in 1985.

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