DeviceClearance

SIGNA Premier— 510(k) K171128

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K171128 for SIGNA Premier, Substantially Equivalent on 2017-07-14. 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
Traditional
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 K171128

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 K171128.

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