Device class
Class II
Regulation 892.1650
Total clearances
10
2021-03-05 → 2026-06-05
Definition
What is Image-Intensified Fluoroscopic X-Ray System, Mobile
Fluoroscopy of the human body.
Classification details
Medical specialty
Radiology
Regulation number
892.1650
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 |
| 71020 |
CPT
|
— |
Medium
|
Chest X-ray, 2 views |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-06-05 |
K253296 |
Allengers Medical Systems Limited
|
Digital C-ARM with 3D |
| 2026-01-14 |
K252579 |
Ziehm-Orthoscan, Inc.
|
Orthoscan TAU MVP Mini C-Arm System |
| 2025-11-26 |
K253269 |
Ge Hualun Medical Systems Co. , Ltd.
|
OEC One CFD |
| 2025-11-06 |
K251004 |
Hefei Chimed Intelligent Machine Co., Ltd.
|
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) |
| 2025-07-02 |
K250587 |
Ziehm-Orthoscan, Inc.
|
Orthoscan TAU Mini C-Arm |
| 2025-01-14 |
K243452 |
Ziehm-Orthoscan, Inc.
|
Orthoscan VERSA Mini C-Arm |
| 2024-12-27 |
K240828 |
Ge Hualun Medical Systems Co. , Ltd.
|
OEC One ASD |
| 2024-03-28 |
K233669 |
Ge Oec Medical Systems, Inc.
|
OEC 3D |
| 2021-10-21 |
K213113 |
Orthoscan, Inc.
|
Orthoscan Tau Mini C-Arm |
| 2021-03-05 |
K203346 |
Ge Oec Medical Systems, Inc.
|
OEC 3D |