Skip to content

Tringa Ultrasound Imaging System, Model 50L

by Pie Medical

510(k) K033604

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 NumberK033604 Date15 Dec 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  • Withdrawn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
IYO
Device Class
Class II
Regulation
21 CFR Part 892.1560
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 Tringa Ultrasound Imaging System, Model 50L is a diagnostic ultrasound imaging system designed for use by or under the direction of a physician. It performs general non-invasive and invasive diagnostic ultrasound imaging studies, including abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular, and musculoskeletal applications.

This device is authorized under FDA 510(k) clearance K033604. It is intended for clinical settings where diagnostic imaging is required for the specified anatomical and procedural applications.

Other devices from Pie Medical

See all devices from Pie Medical →

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 clinical applications is the Tringa Model 50L designed for?

    The system is intended for non-invasive and invasive diagnostic ultrasound imaging studies. Supported applications include abdominal, neonatal cephalic, pediatric, peripheral vascular, small organs, intraoperative abdominal, intraoperative vascular, and musculoskeletal procedures.

  • Who is authorized to operate the Tringa Ultrasound Imaging System?

    This device is designed for use by a physician or under the direct supervision of a physician to ensure appropriate clinical application during diagnostic imaging studies.

  • What is the regulatory status of this imaging system?

    The Tringa Ultrasound Imaging System, Model 50L, is authorized under FDA 510(k) clearance K033604. It was determined to be substantially equivalent to existing devices through a traditional submission process reviewed by the Radiology advisory committee.