Atlas FDA

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

FDA 510(k) clearance K241582 · decided 2024-09-12

Clearance details

K-number
K241582
Device name
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
Applicant
Canon Medical Systems Corporation
Decision
Substantially Equivalent
Date received
2024-06-03
Decision date
2024-09-12
Days to decision
101 days
Clearance type
Traditional
Product code
IYN
Device class
2
Regulation number
892.1550
Medical specialty
Radiology
Advisory committee
Radiology
Location
Otawara-Shi, JP
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Venue Go (K261668)GE Medical Systems Ultrasound and Primary care Diagnostics, LLC2026-08-07
Alturion Series Diagnostic Ultrasound System (K262311)Philips Ultrasound, LLC2026-08-04
LOGIQ Focus (K261835)GE Medical Systems Ultrasound and Primary Care Diagnostics2026-07-30
Handheld Ultrasound Scanner (K261288)IMGFAX CO., LTD.2026-07-30
V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; (K261412)Samsung Medison Co., Ltd.2026-07-28
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (K261211)Philips Ultrasound, LLC2026-07-27
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081)Beijing Konted Medical Technology Co.,Ltd2026-07-23
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272)Esonic Technology (Wuhan) Co., Ltd.2026-07-23
Alturion Series Diagnostic Ultrasound System (K260667)Philips Ultrasound, LLC2026-06-29
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844)Siemens Medical Solutions USA, Inc.2026-06-16
ES-Series (K260748)E-Scopics2026-06-09
EPIQ Series Diagnostic Ultrasound System (K260123)Philips Ultrasound, LLC2026-05-27

Recalls involving this device

No recalls on record reference this clearance.