FDA 510(k)

MapRT

K-Number: K243301 · 2025-05-19

Decision Date2025-05-19

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MapRT is the device name listed in this FDA 510(k) record. The listed applicant is Vision Rt, Ltd.. It received FDA 510(k) clearance on 2025-05-19 under 510(k) number K243301. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MapRT?

MapRT is a medical device that received FDA 510(k) clearance on 2025-05-19. The listed applicant is Vision Rt, Ltd.. The 510(k) number is K243301.

When did MapRT receive FDA 510(k) clearance?

MapRT received FDA 510(k) clearance on 2025-05-19, under 510(k) number K243301.

Who is the listed applicant for MapRT?

The FDA 510(k) record lists Vision Rt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MapRT?

The FDA product code for MapRT is IYE.

Other records listing Vision Rt, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253012AlignRT Plus (8.0)K233622AlignRT Plus K231185MapRT K212583AlignRT Plus K203387AlignRT Plus K193431AlignRT Plus

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.