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Sonalis

by Smith Associates

510(k) K100204

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100204 Date19 Feb 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

Sonalis is an ultrasound system designed for diagnostic imaging applications. It functions by utilizing ultrasonic waves to produce images of internal body structures.

This device is supplied as a medical system and has received FDA 510(k) clearance. It is identified by the K-number K100204 and is classified under the radiology advisory committee.

Questions

AI-generated answers, 23 Sep 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 primary function of the Sonalis system?

    The Sonalis is an ultrasound system engineered for diagnostic imaging applications. It operates by emitting ultrasonic waves that capture and produce images of internal body structures for clinical assessment.

  • Has the Sonalis system received regulatory clearance?

    Yes, the Sonalis system has received FDA 510(k) clearance under the submission number K100204. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

  • Under which regulatory category is this device classified?

    The Sonalis system is classified under the radiology advisory committee, which oversees diagnostic imaging equipment. It is assigned the product code ITX, reflecting its specific regulatory filing category.