510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QRGClass II

Ultrasound Guided Nerve Block Assist

21 CFR 868.1980 / Anesthesiology
FDA source (opens on fda.gov)

QRG is the FDA product code for Ultrasound Guided Nerve Block Assist, a class II device type, regulated under 21 CFR 868.1980. FDA's definition for this code reads: "This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QRG
Device name
Ultrasound Guided Nerve Block Assist
FDA definition
This device provides real-time interpretation and enhanced visualization of live ultrasound images by highlighting anatomical landmarks in preparation for performing regional anesthesia.
Regulation
21 CFR 868.1980
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QRG

By decision year
3 clearances under product code QRG with a decision year between 2022 and 2025, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QRG by decision year
YearClearances
20221
20231
20251

Applicants with the most clearances

Product code QRG
Applicants holding the most 510(k) clearances under product code QRG
ApplicantClearances
Intelligent Ultrasound Limited2
Smart Alfa Teknoloji San. ve Tic. A.S.1

Companies listing this code with FDA

Companies whose registered establishments list this code