DeviceClearance

Medical Radiation Dosimetry System microSTARii— 510(k) K192196

Substantially Equivalent

Landauer

FDA 510(k) clearance K192196 for Medical Radiation Dosimetry System microSTARii, Substantially Equivalent on 2019-12-27. Applicant: Landauer. Device class: 2.

Clearance details

Applicant
Landauer
Product code
Code IYE
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Glenwood, IL, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code IYE

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Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

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 K192196

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 K192196.

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