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FDA 510(k)

CAD - Lower GI (EC07-01)

K-Number: K252853 · 2026-08-05

ApplicantXiamen Inno Medical Technology Co., Ltd.
Decision Date2026-08-05
Product CodeQNP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAD - Lower GI (EC07-01) is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Inno Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-05 under 510(k) number K252853. 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 CAD - Lower GI (EC07-01)?

CAD - Lower GI (EC07-01) is a medical device that received FDA 510(k) clearance on 2026-08-05. The listed applicant is Xiamen Inno Medical Technology Co., Ltd.. The 510(k) number is K252853.

When did CAD - Lower GI (EC07-01) receive FDA 510(k) clearance?

CAD - Lower GI (EC07-01) received FDA 510(k) clearance on 2026-08-05, under 510(k) number K252853.

Who is the listed applicant for CAD - Lower GI (EC07-01)?

The FDA 510(k) record lists Xiamen Inno Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAD - Lower GI (EC07-01)?

The FDA product code for CAD - Lower GI (EC07-01) is QNP.

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 CorporationK261369GI 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.K252586CADDIEOdin Medical Limited

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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