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SA 9900 Plus Diagnostic Ultrasound System

by Medison America, Inc.

510(k) K032329

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 NumberK032329 Date6 Aug 2003ClearedStatusActive

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  • Withdrawn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
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The SA 9900 Plus Diagnostic Ultrasound System is a mobile, software-controlled diagnostic ultrasound system. It acquires ultrasound data using piezoelectric transducers ranging from 1.0 to 20.0 MHz and displays images in B-mode, M-mode, Color-Flow, CW, PW, and Power Doppler.

This Class II device is manufactured by Medison America, Inc. and received FDA 510(k) clearance under K032329 in 2003. It is filed under the radiology advisory committee for clinical use.

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Questions

AI-generated answers, 21 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 imaging modes does the SA 9900 Plus support?

    The system is capable of displaying ultrasound data in several modes, including B-mode, M-mode, Color-Flow, Continuous Wave (CW), Pulsed Wave (PW), and Power Doppler to support various diagnostic requirements.

  • What is the frequency range of the transducers used with this system?

    The SA 9900 Plus utilizes piezoelectric transducers that operate within a frequency range of 1.0 to 20.0 MHz to acquire diagnostic ultrasound data.

  • What is the regulatory status of the SA 9900 Plus?

    This device is a Class II system that received FDA 510(k) clearance under K032329 in 2003. It is filed under the radiology advisory committee for clinical use.