Sonos 500 And Sonos 1000 Ultrasound Imaging System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905728 ↗

FDA Product Code

DPT

Device Class

Class II

Regulation

21 CFR Part 870.2120

Advisory Committee

Cardiovascular

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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• What is the Sonos 500 and Sonos 1000 Ultrasound Imaging System used for?

  It is used for ultrasound imaging, specifically as a Probe, Blood-Flow, Extravascular device, intended for cardiovascular medical specialty applications to provide imaging capabilities for medical professionals.

• Is the Sonos 500 and Sonos 1000 Ultrasound Imaging System reusable or single-use?

  The device is reusable, as stated in the device data, and is designed for repeated use in a medical setting with appropriate storage and handling instructions provided by the manufacturer.

• How is the Sonos 500 and Sonos 1000 Ultrasound Imaging System supplied and regulated?

  It is supplied by Hewlett-Packard Co., cleared by the FDA via 510(k) traditional pathway under K905728, classified as Class II with product code DPT, and regulated under 870.2120 for cardiovascular use.