Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1650](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1650) → OWB — Interventional Fluoroscopic X-Ray System # OWB · Interventional Fluoroscopic X-Ray System _Radiology · 21 CFR 892.1650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB ## Overview - **Product Code:** OWB - **Device Name:** Interventional Fluoroscopic X-Ray System - **Regulation:** [21 CFR 892.1650](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1650) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K252229.md) | BELLIGER ACE | Genoray Co., Ltd. | Apr 2, 2026 | SESE | | [K252099](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K252099.md) | Trinias | Shimadzu Corporation | Mar 24, 2026 | SESE | | [K253584](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K253584.md) | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) | Canon Medical Systems Corporation | Mar 10, 2026 | SESE | | [K252500](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K252500.md) | CARA System | Cara Medical, Ltd. | Feb 20, 2026 | SESE | | [K251992](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251992.md) | ArmSure Fluoroscopic Positioning System | Savfe Co. , Ltd. | Feb 11, 2026 | SESE | | [K254186](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K254186.md) | Azurion R3.1 | Philips Medical Systems B.V. | Jan 16, 2026 | SESE | | [K252068](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K252068.md) | MC2 Portable X-ray System | Oxos Medical | Dec 22, 2025 | SESE | | [K251893](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251893.md) | SKAN C PULSAR | Skanray Technologies Limited | Dec 16, 2025 | SESE | | [K251199](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251199.md) | Allia Moveo | GE Medical Systems SCS | Dec 9, 2025 | SESE | | [K250241](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K250241.md) | Cios Select | Siemens Medical Solutions USA, Inc. | Nov 4, 2025 | SESE | | [K251827](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251827.md) | Azurion R3.1 | Philips Medical Systems B.V. | Oct 24, 2025 | SESE | | [K251602](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251602.md) | Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging | Canon Medical Systems Corporation | Oct 10, 2025 | SESE | | [K251523](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251523.md) | Cios Spin | Siemens Medical Solutions USA, Inc. | Jul 29, 2025 | SESE | | [K243432](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K243432.md) | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG | Jul 22, 2025 | SESE | | [K250660](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K250660.md) | LUMINOS Q.namix T; LUMINOS Q.namix R | Siemens Medical Solutions | Jul 14, 2025 | SESE | | [K251520](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K251520.md) | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | Jul 9, 2025 | SESE | | [K243884](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K243884.md) | TAVIPILOT | Caranx Medical | Jul 7, 2025 | SESE | | [K250010](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K250010.md) | EXTRON 3; EXTRON 5; EXTRON 7 | DRTECH Corporation | Jun 10, 2025 | SESE | | [K243411](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K243411.md) | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | May 19, 2025 | SESE | | [K242731](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB/K242731.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/OWB) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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