ORTHONE— 510(k) K001773

Name: FDA 510(k) clearance K001773
Creator: U.S. Food and Drug Administration
Published: 2000-08-18

Substantially Equivalent

Oni, Inc.

FDA 510(k) clearance K001773 for ORTHONE, Substantially Equivalent on 2000-08-18. Applicant: Oni, Inc.. Device class: 2.

Clearance details

Applicant: Oni, Inc.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2000-06-12
Decision date: 2000-08-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Andover, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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 →

Recalls naming K001773

K-number listed on FDA's recall record

Z-0621-2022 — GE Healthcare MR superconducting magnets, a component of GE Healthcare Orthone (1.0T MSK Extreme) System, nuclear magnetic resonance imaging system.Class II·Ongoing·GE Healthcare, LLC·20211223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001773.

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