Chrysalis Intelligence · Product Codes · MUI

MUI · Media, Coupling, Ultrasound

Radiology · 7 clearances · 6 unique sponsors

Device class
Class II
Regulation 892.1570
Total clearances
7
2021-12-22 → 2026-06-17
Last 12 months
2
Unique sponsors
6
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1570
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Hony Medical Co., Ltd. 2 0 2024-07-24
Anhui Deepblue Medical Technology Co., Ltd. 1 0 2024-09-19
Edgecare, Inc. 1 1 2026-04-24
Foshan Pingchuang Medical Technology Co., Ltd. 1 1 2026-06-17
Ultrast, Inc. 1 0 2021-12-22
Jianerkang Medical Co., Ltd. 1 0 2023-12-15
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.

CodeTypeDescriptionConfidenceRationale
A4649 HCPCS Surgical supply; miscellaneous ✓ CMS-verified description High HCPCS for ultrasound gel or coupling medium supplies
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-17 K253255 Foshan Pingchuang Medical Technology Co., Ltd. Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
2026-04-24 K252337 Edgecare, Inc. EdgeFlow Gel Pad
2024-09-19 K242167 Anhui Deepblue Medical Technology Co., Ltd. Sterile and Non-Sterile Ultrasonic Coupling Agent
2024-07-24 K241789 Hony Medical Co., Ltd. Non-Sterile Ultrasound Transmission Gels
2023-12-15 K232957 Jianerkang Medical Co., Ltd. Sterile and Non-Sterile Ultrasound Gels
2022-08-30 K221999 Hony Medical Co., Ltd. Ultrasound Transmission Gels
2021-12-22 K211691 Ultrast, Inc. Ultrast Gel