DeviceClearance

Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T— 510(k) K160618

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K160618 for Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, Substantially Equivalent on 2016-06-09. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant
Ge Medical Systems, LLC
Product code
Code LNH
Device class
Class 2
Regulation
21 CFR 892.1000
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Waukesha, WI, US
Download summary PDFView on FDA.gov ↗

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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, through . 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 K160618

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160618.

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