IYO · System, Imaging, Pulsed Echo, Ultrasonic

Device class

Class II

Regulation 892.1560

Total clearances

2020-01-23 → 2026-07-24

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1560

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Echosens	4	0	2023-03-02
Sonic Incytes	4	0	2024-09-04
Biobot Surgical Pte., Ltd.	3	0	2023-12-21
Mcube Technology Co., Ltd.	3	0	2020-08-19
Rivanna Medical, Inc.	3	2	2026-07-24
QT Imaging Holdings, Inc.	2	1	2026-03-04
Edgecare, Inc.	2	1	2026-04-17
Wuxi Hisky Medical Technologies Co., Ltd.	2	0	2025-06-17
Siemens Medical Solutions USA, Inc.	2	0	2024-06-12
Suzhou Peaksonic Medical Technology Co., Ltd.	2	0	2022-07-01
Bard Access Systems, Inc. (C.R. Bard, Inc.)	2	0	2023-09-11
Quantel Medical	2	0	2024-04-26
Eieling Technology (Shenzhen) Limited	2	1	2026-02-06
Thd Spa	2	0	2021-06-24
Fcu Co., Ltd.	2	0	2024-06-26
Butterfly Network, Inc.	2	0	2023-03-31
Infraredx, Inc.	1	0	2021-12-07
Bard Access Systems, Inc.	1	0	2024-02-18
Eieling Technology Limited	1	0	2024-02-12
Accutome, Inc. Doing Business AS Keeler USA	1	0	2025-07-11
Echolight S.P.A	1	0	2022-03-16
Contec Medical Systems Co.,Ltd	1	0	2024-05-03
Maui Imaging	1	0	2023-10-25
Sonavex, Inc.	1	0	2025-04-23
Philips Image Guided Therapy Corporation	1	1	2026-02-24

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
76999	CPT	—	High	Unlisted ultrasound procedure; pulsed echo ultrasound systems bill under specific anatomic codes or this unlisted code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-24	K253452	Rivanna Medical, Inc.	Accuro 3S
2026-06-18	K260190	ROPCA ApS	ARTHUR
2026-04-17	K252237	Edgecare, Inc.	EdgeFlow UW20
2026-04-09	K254021	Rivanna Medical, Inc.	Accuro XV
2026-03-04	K253898	QT Imaging Holdings, Inc.	QT Scanner 2000 Model A
2026-02-24	K253714	Philips Image Guided Therapy Corporation	IntraSight Plus
2026-02-06	K253221	Eieling Technology (Shenzhen) Limited	Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
2025-09-30	K250331	Astrasono Technology Co., Ltd.	Astrasono A3Pro Bladder Scanner (A3Pro)
2025-08-01	K250381	DeepSight Technology, Inc.	Deepsight NeedleVue LC1 Ultrasound System
2025-07-11	K243227	Accutome, Inc. Doing Business AS Keeler USA	B-Scan
2025-06-26	K251728	Sonic Incytes Medical Corp	Velacur One (LI-1100)
2025-06-17	K243880	Wuxi Hisky Medical Technologies Co., Ltd.	Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
2025-05-23	K243937	Rivanna Medical, Inc.	Accuro 3S
2025-04-23	K243479	Sonavex, Inc.	EchoGuide (Version 1)
2024-11-19	K242496	Eieling Technology (Shenzhen) Limited	Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)
2024-10-07	K241029	Verdure Imaging	SpineUs System
2024-09-04	K233977	Sonic Incytes	Velacur
2024-06-26	K233579	Fcu Co., Ltd.	SC1 Handheld Ultrasound Imaging system (Model: SC1)
2024-06-12	K233613	Siemens Medical Solutions USA, Inc.	ACUSON SC2000 Diagnostic Ultrasound System
2024-05-03	K232895	Contec Medical Systems Co.,Ltd	B-Ultrasound Diagnostic System
2024-04-26	K232302	Quantel Medical	Pocket III
2024-03-06	K231677	Edgecare, Inc.	EdgeFlow UH10
2024-02-18	K240146	Bard Access Systems, Inc.	BD Prevue II Peripheral Vascular Access System
2024-02-12	K233401	Eieling Technology Limited	Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
2023-12-29	K230986	Avantsonic Technology Co., Ltd.	Bladder Scanner