PORTABLE MEDICAL ULTRASOUND SCANNER— 510(k) K800434

Name: FDA 510(k) clearance K800434
Creator: U.S. Food and Drug Administration
Published: 1980-04-10

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K800434 for PORTABLE MEDICAL ULTRASOUND SCANNER, Substantially Equivalent on 1980-04-10. Applicant: Bion Ent., Ltd.. Device class: 2.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1980-02-27
Decision date: 1980-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Bion Ent., Ltd.

view all

K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM1993-06-15
K901054 — BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE1990-04-05
K894622 — VARICELLA ZOSTER VIRUS1989-10-24
K894623 — RESPIRATORY SYNCYTIAL VIRUS1989-10-16
K894624 — MUMPS VIRUS1989-10-16

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.