Chrysalis Intelligence · Product Codes · MUE

MUE · Full Field Digital, System, X-Ray, Mammographic

Radiology · 19 clearances · 12 unique sponsors

Device class
Class II
Regulation 892.1715
Total clearances
19
2020-05-15 → 2026-06-18
Last 12 months
3
Unique sponsors
12
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1715
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
Siemens Medical Solutions USA, Inc. 3 1 2026-06-18
GE Healthcare 3 0 2021-08-06
Rayence Co., Ltd. 2 0 2025-03-12
Planmed OY 2 0 2022-07-18
Vieworks Co., Ltd. 2 1 2026-05-28
DRTECH Corporation 1 0 2023-01-26
GE Medical Systems SCS 1 1 2026-03-24
Vmi Tecnologias Ltda 1 0 2022-03-01
Genoray Co., Ltd. 1 0 2025-07-17
Fujifilm Corporation 1 0 2022-05-27
Metaltronica Spa 1 0 2021-12-15
Ims Giotto S.P.A. 1 0 2020-06-18
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
77065 CPT High CPT for diagnostic mammography, unilateral digital
77066 CPT High CPT for diagnostic mammography, bilateral digital
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-18 K253678 Siemens Medical Solutions USA, Inc. MAMMOMAT B.brilliant (11372950)
2026-05-28 K254092 Vieworks Co., Ltd. Bellalun 2D (VDMS-1000S)
2026-03-24 K260087 GE Medical Systems SCS Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
2025-07-17 K243420 Genoray Co., Ltd. HESTIA
2025-03-12 K243849 Rayence Co., Ltd. 2430TCA with Xmaru W
2025-01-16 K241113 Vieworks Co., Ltd. VIVIX-M
2024-03-27 K233539 Siemens Medical Solutions USA, Inc. MAMMOMAT B.brilliant
2023-01-26 K220073 DRTECH Corporation RMF-2000
2022-07-18 K211720 Planmed OY Planmed Clarity 2D, Planmed Clarify S
2022-05-27 K212873 Fujifilm Corporation Aspire Cristalle
2022-03-01 K210151 Vmi Tecnologias Ltda Digimamo D
2021-12-15 K202822 Metaltronica Spa Helianthus
2021-08-06 K211725 GE Healthcare Senographe Pristina
2021-06-22 K211215 GE Healthcare SenoBright HD
2021-06-21 K202902 Rayence Co., Ltd. 2430MCA with Xmaru W
2020-10-23 K192317 Planmed OY Planmed Clarity 2D and Clarity S
2020-06-18 K200424 Ims Giotto S.P.A. Giotto Class (Models - 3000X-YY and 4000X-YY)
2020-06-12 K193166 Siemens Medical Solutions USA, Inc. MAMMOMAT Revelation
2020-05-15 K193334 GE Healthcare Pristina Serena Bright