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Cypress Ultrasound System

by Acuson Corp.

510(k) K021497

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 · Special NumberK021497 Date9 Jul 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0744-04 FDA Unclassified (pre-2012) initiated 2 Feb 2004

    software problem - mode does not appear on screen

    • Terminated Z-0975-03 FDA Unclassified (pre-2012) initiated 1 Apr 2003

    software problem - loss of data

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  • Withdrawn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

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