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Diasonics Itnraoperative Probes

by Diasonics Ultrasound

510(k) K961002

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 NumberK961002 Date22 Jan 1997ClearedStatusActive

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Diasonics Intraoperative Probes are intra-operative ultrasound probes designed for real-time imaging during surgical procedures. These devices facilitate visualisation of anatomical structures and guidance for precise interventions, such as tumour resection or biopsy, by providing immediate feedback via ultrasound imaging.

These probes are intended for single-use in sterile surgical environments and are classified under product code ITX. They are regulated under FDA 510(k) clearance (K961002) and were determined substantially equivalent to a predicate device by the Radiology Advisory Committee in 1997. No additional regulatory markings or sterility assurances are specified beyond the FDA clearance.

Other devices from Diasonics Ultrasound

Questions

AI-generated answers, 19 Sep 2026

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

  • Are the Diasonics Intraoperative Probes designed for reuse in surgical settings, or are they meant to be used only once per patient?

    The Diasonics Intraoperative Probes are explicitly designed for single-use only in sterile surgical environments. This is a key feature to ensure patient safety and prevent cross-contamination, as outlined in the device description.

  • What types of surgical procedures are these probes commonly used for, and how do they assist during surgery?

    These probes are used for real-time ultrasound imaging during surgery to visualize anatomical structures and guide interventions like tumour resection or biopsy. They provide immediate feedback, helping surgeons make precise decisions intraoperatively without needing additional imaging outside the operating room.

  • How are the Diasonics Intraoperative Probes regulated by the FDA, and what does the 'substantially equivalent' determination mean for their use?

    The probes are regulated under FDA 510(k) clearance (K961002), meaning they were deemed substantially equivalent to a predicate device by the Radiology Advisory Committee in 1997. This classification confirms they meet FDA safety and effectiveness standards for their intended use as intraoperative ultrasound tools, ensuring they comply with regulatory requirements for medical devices in this category.

  • What product code classification does the Diasonics Intraoperative Probe fall under, and what does this indicate about its regulatory pathway?

    The probe is classified under FDA product code ITX, which categorizes it as an intraoperative imaging device. This classification helps streamline its regulatory review process, as it aligns with devices used during surgery for real-time visualization, ensuring consistency with similar medical imaging tools.