Device class
Class II
Regulation 892.5900
Total clearances
4
2022-01-11 → 2025-12-03
Classification details
Medical specialty
Radiology
Regulation number
892.5900
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 |
| 77799 |
CPT
|
— |
High
|
Unlisted radiotherapy procedure; therapeutic X-ray systems are radiation therapy equipment |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-12-03 |
K250692 |
Voxel Ray Solutions, LLC
|
GentleBeam (GB1000) |
| 2025-01-10 |
K241174 |
Carl Zeiss Meditec, AG
|
INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) |
| 2023-07-13 |
K230611 |
Xstrahl, Ltd.
|
X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) |
| 2022-01-11 |
K213942 |
Nucletron B.V.
|
Esteya |