OWB · Interventional Fluoroscopic X-Ray System
Radiology · 21 CFR 892.1650 · Class 2
Overview
| Product Code | OWB |
|---|---|
| Device Name | Interventional Fluoroscopic X-Ray System |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 316)
Showing 20 most recent of 316 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252229 | BELLIGER ACE | Genoray Co., Ltd. | Apr 2, 2026 | SESE |
| K252099 | Trinias | Shimadzu Corporation | Mar 24, 2026 | SESE |
| K253584 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | Mar 10, 2026 | SESE |
| K252500 | CARA System | Cara Medical, Ltd. | Feb 20, 2026 | SESE |
| K251992 | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | Feb 11, 2026 | SESE |
| K254186 | Azurion R3.1 | Philips Medical Systems B.V. | Jan 16, 2026 | SESE |
| K252068 | MC2 Portable X-ray System | Oxos Medical | Dec 22, 2025 | SESE |
| K251893 | SKAN C PULSAR | Skanray Technologies Limited | Dec 16, 2025 | SESE |
| K251199 | Allia Moveo | GE Medical Systems SCS | Dec 9, 2025 | SESE |
| K250241 | Cios Select | Siemens Medical Solutions USA, Inc. | Nov 4, 2025 | SESE |
| K251827 | Azurion R3.1 | Philips Medical Systems B.V. | Oct 24, 2025 | SESE |
| K251602 | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | Oct 10, 2025 | SESE |
| K251523 | Cios Spin | Siemens Medical Solutions USA, Inc. | Jul 29, 2025 | SESE |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG | Jul 22, 2025 | SESE |
| K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | Jul 14, 2025 | SESE |
| K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | Jul 9, 2025 | SESE |
| K243884 | TAVIPILOT | Caranx Medical | Jul 7, 2025 | SESE |
| K250010 | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | Jun 10, 2025 | SESE |
| K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | May 19, 2025 | SESE |
| K242731 | MasteRad MiniX Mobile Digital Imaging System (Mini-X) | Medicatech USA, Inc. | May 16, 2025 | SESE |
Top Applicants
- Siemens Medical Solutions USA, Inc. — 35 clearances
- Philips Medical Systems Nederland B.V. — 28 clearances
- Ziehm Imaging GmbH — 16 clearances
- Toshibamedical Systems Corporation — 13 clearances
- Canon Medical Systems Corporation — 12 clearances
