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) → JAA — System, X-Ray, Fluoroscopic, Image-Intensified # JAA · System, X-Ray, Fluoroscopic, Image-Intensified _Radiology · 21 CFR 892.1650 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA ## Overview - **Product Code:** JAA - **Device Name:** System, X-Ray, Fluoroscopic, Image-Intensified - **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 299) Showing 20 most recent of 299 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251650](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K251650.md) | Insight Enhanced™ DRF (EN-1002-01) | Imaging Engineering, LLC | Sep 16, 2025 | SESE | | [K242488](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K242488.md) | Soteria E-View | Omega Medical Imaging, LLC | Jan 6, 2025 | SESE | | [K242948](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K242948.md) | Adora DRFi (04550010) | Nrt X-Ray A/S | Dec 23, 2024 | SESE | | [K233380](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K233380.md) | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | Jun 26, 2024 | SESE | | [K233945](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K233945.md) | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | Jan 11, 2024 | SESE | | [K232910](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K232910.md) | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | Oct 19, 2023 | SESE | | [K232526](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K232526.md) | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | Sep 12, 2023 | SESE | | [K220871](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K220871.md) | Nautilus | Dornier Medtech America, Inc. | Apr 18, 2022 | SESE | | [K212890](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K212890.md) | Nyquist.IQ | Omega Medical Imaging, LLC | Dec 13, 2021 | SESE | | [K212837](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K212837.md) | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | Sep 21, 2021 | SESE | | [K212145](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K212145.md) | DR 800 with DSA, DR 800 | Agfa N.V. | Aug 31, 2021 | SESE | | [K210469](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K210469.md) | Insight Agile DRF | Imaging Engineering, LLC | Jul 27, 2021 | SESE | | [K203428](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K203428.md) | Ziehm Vision RFD | Ziehm Imaging GmbH | Mar 17, 2021 | SESE | | [K203010](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K203010.md) | Platinum dRF Imaging System | Apelem-Dms Group | Jan 22, 2021 | SESE | | [K200965](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K200965.md) | XR-MX/1000 | Karl Storz Endoscopy America, Inc. | Dec 29, 2020 | SESE | | [K203087](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K203087.md) | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | Dec 3, 2020 | SESE | | [K202235](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K202235.md) | ArtPIX DRF | Cmt Medical Technologies, Ltd. | Sep 3, 2020 | SESE | | [K200396](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K200396.md) | Insight Enhanced DRF Digital Imaging System | Imaging Engineering, LLC | Mar 6, 2020 | SESE | | [K191713](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K191713.md) | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) | Omega Medical Imaging, LLC | Oct 4, 2019 | SESE | | [K191504](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA/K191504.md) | PowerDR | Radiology Information Systems, Inc. | Aug 16, 2019 | SESE | ## Top Applicants - Toshiba America Medical Systems, In.C — 13 clearances - Siemens Medical Solutions USA, Inc. — 10 clearances - Shimadzu Medical Systems — 10 clearances - General Electric Co. — 10 clearances - Fischer Imaging Corp. — 10 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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