Class Class II

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 (K222584)

K222584 2023-04-26 Traditional
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Description

EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 by Olympus Medical Systems Corporation, an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK222584
Clearance Date2023-04-26
Clearance TypeTraditional
Product CodeFET
Regulation Number876.1500

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Predicate lineage for K222584

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 (K222584) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K131780EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corp.2013

Later devices that cite this one as their predicate

Devices that cite K222584
K numberDeviceApplicantYear
K250432Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500...Olympus Medical Systems Corporation2025

Trace the full predicate network for K222584

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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