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Grayline Imaging System

by Sonics Research Corp.

510(k) K811520

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811520 Date2 Jul 1981ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
HEM
Device Class
Class II
Regulation
21 CFR Part 884.2225
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Grayline Imaging System is an Ultrasonic Obstetric-Gynecologic Imager, classified under FDA product code HEM. As a second-class device, it is designed for real-time ultrasound imaging to visualize fetal and gynecological structures, aiding in diagnostic assessments during obstetrics and gynecology procedures. Its primary function aligns with obstetric and gynecologic imaging needs, providing clinicians with visual data for monitoring pregnancies and evaluating reproductive health conditions.

This system is supplied as a reusable medical device and is intended for use in clinical settings such as hospitals and obstetrics/gynecology clinics. The device received FDA clearance under 510(k) number K811520 in 1981, with no explicit mention of sterility requirements or MRI safety in the available data. It operates under regulatory classification 2 (Class II) under FDA regulation 884.2225, adhering to standards for obstetric-gynecologic imaging devices. No third-party certifications or additional regulatory markings are referenced beyond the FDA clearance.