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FDA 510(k)

ME-APDS™; MAGENTIQ-COLO™

K-Number: K223473 · 2023-07-25

ApplicantMagentiq Eye, Ltd.
Decision Date2023-07-25
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ME-APDS™; MAGENTIQ-COLO™ is the device name listed in this FDA 510(k) record. The listed applicant is Magentiq Eye, Ltd.. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K223473. 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 ME-APDS™; MAGENTIQ-COLO™?

ME-APDS™; MAGENTIQ-COLO™ is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Magentiq Eye, Ltd.. The 510(k) number is K223473.

When did ME-APDS™; MAGENTIQ-COLO™ receive FDA 510(k) clearance?

ME-APDS™; MAGENTIQ-COLO™ received FDA 510(k) clearance on 2023-07-25, under 510(k) number K223473.

Who is the listed applicant for ME-APDS™; MAGENTIQ-COLO™?

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

What is the FDA product code for ME-APDS™; MAGENTIQ-COLO™?

The FDA product code for ME-APDS™; MAGENTIQ-COLO™ is QNP.

Other records listing Magentiq Eye, 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.

K260724MAGENTIQ-COLO (ME-APDS)K252178MAGENTIQ-COLO (ME-APDS)K244023MAGENTIQ-COLO (ME-APDS)

Related Devices (Code: QNP)

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.

K260567EW10-EC02 Endoscopy Support ProgramFujifilm CorporationK252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd.K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd.K260724MAGENTIQ-COLO (ME-APDS)Magentiq Eye, Ltd.K253664SKOUT systemIterative HealthK252178MAGENTIQ-COLO (ME-APDS)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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