MARK V DUPLEX ULTRASONIC SCAN SYS.— 510(k) K802438

Name: FDA 510(k) clearance K802438
Creator: U.S. Food and Drug Administration
Published: 1981-01-21

Substantially Equivalent

Advanced Technology Laboratories, Inc.

FDA 510(k) clearance K802438 for MARK V DUPLEX ULTRASONIC SCAN SYS., Substantially Equivalent on 1981-01-21. Applicant: Advanced Technology Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Technology Laboratories, Inc.
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 1980-10-06
Decision date: 1981-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ITX

view all

K261170 — BA-004CC2026-08-12
K254143 — EM-TECH Passive Ultrasound Probe Strap2026-08-10
K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K262474 — ND Needle Guidance System2026-07-27
K261014 — Accuro® 3S Needle Guide Kit2026-07-24

More clearances from Advanced Technology Laboratories, Inc.

view all

Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.