Device class
Class II
Regulation 892.1715
Total clearances
20
2020-05-15 → 2026-09-02
Classification details
Medical specialty
Radiology
Regulation number
892.1715
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| 77065 |
CPT
|
— |
High
|
CPT for diagnostic mammography, unilateral digital |
| 77066 |
CPT
|
— |
High
|
CPT for diagnostic mammography, bilateral digital |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-02 |
K254090 |
Hologic, Inc.
|
I-View® |
| 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 |