DeviceClearance

MapRT— 510(k) K231185

Substantially Equivalent

Vision Rt, Ltd.

FDA 510(k) clearance K231185 for MapRT, Substantially Equivalent on 2023-06-23. Applicant: Vision Rt, Ltd.. Device class: 2.

Clearance details

Applicant
Vision Rt, Ltd.
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
London, GB
Download summary PDFView on FDA.gov ↗

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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 →

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