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Imago C21 Diagnostic Ultrasound System

by Saset (Chengdu), Inc.

510(k) K090059

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 NumberK090059 Date30 Apr 2009ClearedStatusActive

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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Imago C21 Diagnostic Ultrasound System is a Class II medical imaging device classified as a diagnostic ultrasound system. It generates real-time visual images of internal organs and structures using high-frequency sound waves, enabling clinicians to assess anatomical and pathological conditions in various diagnostic applications. The system adheres to the Acoustic Output Measurement Standard for Diagnostic Ultrasound (UD-2) as defined by the National Electrical Manufacturers Association (NEMA).

This device is intended for use in radiology departments and clinical settings where ultrasound imaging is required. It is supplied as a reusable medical instrument and is not single-use. The system supports multiple diagnostic applications, including general radiology, abdominal imaging (excluding fetal Doppler), vascular studies, OB/GYN, urology, breast imaging, musculoskeletal assessments, and cardiology. The Imago C21 holds FDA 510(k) clearance under K-number K090059, authorizing its use in the United States for the specified diagnostic purposes.

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