ITX · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-04-17 → 2026-08-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
CIVCO Medical Instruments Co., Inc.	3	0	2023-11-14
Rivanna Medical, Inc.	2	1	2026-07-24
Olympus Medical Systems Corporation	2	1	2025-09-18
Exact Medical Manufacturing	2	0	2023-05-12
Hony Medical Co., Ltd.	2	0	2024-07-03
Boston Scientific Corporation	1	0	2020-04-17
EM-TECH Solutions, Inc.	1	1	2026-08-10
Advance Medical Designs, Inc.	1	0	2023-08-02
Huntleigh Healthcare Limited	1	0	2021-02-19
Fujifilm Corporation	1	1	2026-08-12
Civco Medical Solutions	1	0	2023-12-22
Global Protection Corp.	1	0	2022-06-07
FUJIFILM Healthcare Americas Corporation	1	0	2023-12-13
UC-CARE , Ltd.	1	1	2026-07-30
Accurate Access, LLC	1	1	2026-07-27
GE Medical Systems Ultrasound and Primary Care Diagnostics	1	0	2020-11-20
Vitrolife Sweden AB	1	0	2024-08-30
Medxpress.Pro	1	0	2020-06-05
Parker Laboratories, Inc.	1	0	2024-08-15
Mendaera, Inc.	1	0	2025-07-02

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; diagnostic ultrasound transducers are components of imaging systems
A4649	HCPCS	Surgical supply; miscellaneous ✓ CMS-verified description	Medium	Ultrasound gel or coupling agent for transducer use

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-12	K261170	Fujifilm Corporation	BA-004CC
2026-08-10	K254143	EM-TECH Solutions, Inc.	EM-TECH Passive Ultrasound Probe Strap
2026-07-30	K260161	UC-CARE , Ltd.	SmartGuide Disposable Guides and Grids
2026-07-27	K262474	Accurate Access, LLC	ND Needle Guidance System
2026-07-24	K261014	Rivanna Medical, Inc.	Accuro® 3S Needle Guide Kit
2025-09-18	K250883	Olympus Medical Systems Corporation	ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
2025-07-11	K250762	Olympus Medical Systems Corporation	ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
2025-07-02	K250524	Mendaera, Inc.	Mendaera Guidance System
2025-06-13	K250469	Rivanna Medical, Inc.	Accuro® 3S Needle Guide Kit
2024-08-30	K241662	Vitrolife Sweden AB	Ultrasound Transducer Cover
2024-08-15	K233965	Parker Laboratories, Inc.	UltraDrape UGPIV Barrier and Securement (34-15)
2024-07-03	K241615	Hony Medical Co., Ltd.	Transducer Probe Cover
2023-12-22	K233109	Civco Medical Solutions	TP Pivot Pro Needle Guide
2023-12-13	K231666	FUJIFILM Healthcare Americas Corporation	Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
2023-11-14	K231783	CIVCO Medical Instruments Co., Inc.	VitroPRO
2023-08-02	K223689	Advance Medical Designs, Inc.	Disposable Needle Guides and Grids
2023-05-12	K222460	Exact Medical Manufacturing	Intraoperative Ultrasound Probe Cover
2023-01-11	K221278	Hony Medical Co., Ltd.	Transducer Probe Cover
2022-11-22	K222052	CIVCO Medical Instruments Co., Inc.	VitroPRO
2022-06-07	K213087	Global Protection Corp.	Natural Rubber Latex Ultrasound Transducer Probe Covers
2021-09-13	K211270	CIVCO Medical Instruments Co., Inc.	CIV-Clear cover
2021-08-13	K211969	Exact Medical Manufacturing	EMM Ultrasonic Transducer Cover
2021-02-19	K201425	Huntleigh Healthcare Limited	Disposable Intraoperative Probe (DIOP8)
2020-11-20	K202035	GE Medical Systems Ultrasound and Primary Care Diagnostics	Vscan Air
2020-06-05	K191491	Medxpress.Pro	EZ-Cover

ITX · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances