DeviceClearance

Optima XR200amx, Optima XR220amx— 510(k) K142383

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K142383 for Optima XR200amx, Optima XR220amx, Substantially Equivalent on 2014-09-25. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant
Ge Medical Systems, LLC
Product code
Code IZL
Device class
Class 2
Regulation
21 CFR 892.1720
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 IZL

product code IZL
Other
3
Total
3

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 K142383

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 K142383.

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