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FDA 510(k)

MAGENTIQ-COLO (ME-APDS)

K-Number: K252178 · 2025-10-03

ApplicantMagentiq Eye, Ltd.
Decision Date2025-10-03
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAGENTIQ-COLO (ME-APDS) is a medical device manufactured by Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2025-10-03 under approval number K252178. The device is classified under product code QNP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGENTIQ-COLO (ME-APDS)?

MAGENTIQ-COLO (ME-APDS) is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Magentiq Eye, Ltd.. The 510(k) number is K252178.

When was MAGENTIQ-COLO (ME-APDS) approved by the FDA?

MAGENTIQ-COLO (ME-APDS) received FDA 510(k) clearance on 2025-10-03, under approval number K252178.

What company makes MAGENTIQ-COLO (ME-APDS)?

MAGENTIQ-COLO (ME-APDS) is manufactured by Magentiq Eye, Ltd..

What is the FDA product code for MAGENTIQ-COLO (ME-APDS)?

The FDA product code for MAGENTIQ-COLO (ME-APDS) is QNP.

Other Devices by Magentiq Eye, Ltd.

K223473ME-APDS™; MAGENTIQ-COLO™ K244023MAGENTIQ-COLO (ME-APDS) K260724MAGENTIQ-COLO (ME-APDS)

Related Devices (Code: QNP)

K211326EndoScreenerChengdu Wision Medical Device Co., Ltd. K211951GI GeniusCosmo Artificial Intelligence - Ai, Ltd. DEN200055GI GeniusCosmo Artificial Intelligence - Ai, Ltd. K213686SKOUT SoftwareIterative Scopes, Inc. K230751EW10-EC02 Endoscopy Support ProgramFujifilm Corporation K223473ME-APDS™; MAGENTIQ-COLO™Magentiq Eye, Ltd.

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.

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