Sonos 5500 Imaging System M2424A Version B.o

• • Ongoing Z-2348-2025 FDA Class III ·initiated 3 Jul 2025 ·via K990339, on the same 510(k)

  To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K990339 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Luer Lock Skirt

  Class II

  FDA 510(k) K862451 Active Cleared 31 Oct 1986

• Hp Sonos 100 Cf Ultrasound Imaging System

  Class II

  FDA 510(k) K922184 Active Cleared 30 Jul 1992

• Medical Diag. Ultrasound Instr. 77065

  Class II

  FDA 510(k) K842897 Active Cleared 25 Sep 1984

• Model M1403A Telemetry Monitoring Systems (TMS)

  Class II

  FDA 510(k) K913533 Active Cleared 7 Nov 1991

• Differential Refractive Index Detector

  Class I

  FDA 510(k) K800556 Active Cleared 25 Mar 1980

• Model 80100A, Patient Data Memory

  Class II

  FDA 510(k) K781360 Active Cleared 7 Sep 1978

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