DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE— 510(k) K922604

Name: FDA 510(k) clearance K922604
Creator: U.S. Food and Drug Administration
Published: 1992-10-20

Substantially Equivalent

Biodan Medical Systems, Ltd.

FDA 510(k) clearance K922604 for DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE, Substantially Equivalent on 1992-10-20. Applicant: Biodan Medical Systems, Ltd.. Device class: 2.

Clearance details

Applicant: Biodan Medical Systems, Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1992-06-02
Decision date: 1992-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shirley, NY, 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 Biodan Medical Systems, Ltd.

view all

K932153 — THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME1993-09-07
K930261 — RTM REHABILITATION TREADMILL, MODEL #945-2001993-05-26
K930262 — TREATMENT TABLE, MODEL #825-1001993-03-29
K930259 — TRACTION TABLE MODEL #825-2001993-03-24
K926083 — NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPES1993-02-12

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.