Device class
Class II
Regulation 892.1680
Total clearances
8
2020-06-12 → 2023-04-24
Classification details
Medical specialty
Radiology
Regulation number
892.1680
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Kub Technologies, Inc.
|
4 |
0 |
2021-09-20 |
|
Compai Healthcare (Suzhou) Co.,Ltd |
2 |
0 |
2023-04-24 |
|
Cirdan Imaging, Ltd. |
1 |
0 |
2021-12-22 |
|
Compai Healthcare (Shenzhen) Co.,Ltd |
1 |
0 |
2020-11-18 |
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.
| Code | Type | Description | Confidence | Rationale |
| 71046 |
CPT
|
— |
Medium
|
X-ray equipment service/supply; facility billing varies by context |
Pulse
Most recent 510(k) clearances