Class Class II

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (K242808)

K242808 2025-05-13 Traditional
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Description

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 by Canon Medical Systems Corporation, an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242808
Clearance Date2025-05-13
Clearance TypeTraditional
Product CodeIYN
Regulation Number892.1550

Categories

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Predicate lineage for K242808

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. Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (K242808) cites 2 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnos...Canon Medical Systems Corporation2024
K183525EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FOlympus Medical Systems Corp.2019

Trace the full predicate network for K242808

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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