Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) → MWP — Cabinet, X-Ray System # MWP · Cabinet, X-Ray System _Radiology · 21 CFR 892.1680 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP ## Overview - **Product Code:** MWP - **Device Name:** Cabinet, X-Ray System - **Regulation:** [21 CFR 892.1680](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1680) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) - **3rd-party reviewable:** yes ## Identification A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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. ## Special Controls *Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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. ## Recent Cleared Devices (20 of 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K230140](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K230140.md) | TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | Apr 24, 2023 | SESE | | [K230136](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K230136.md) | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) | Compai Healthcare (Suzhou) Co.,Ltd | Apr 24, 2023 | SESE | | [K213691](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K213691.md) | Solas OR | Cirdan Imaging, Ltd. | Dec 22, 2021 | SESE | | [K210955](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K210955.md) | Kubtec Mozart Supra (XPERT 84) Radiography System | Kub Technologies, Inc. | Sep 20, 2021 | SESE | | [K210957](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K210957.md) | Kubec Xpert 80 Radiography System | Kub Technologies, Inc. | Aug 31, 2021 | SESE | | [K210956](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K210956.md) | Kubtec Mozart (XPERT42) | Kub Technologies, Inc. | Aug 31, 2021 | SESE | | [K202713](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K202713.md) | TrueView 100 Pro | Compai Healthcare (Shenzhen) Co.,Ltd | Nov 18, 2020 | SESE | | [K200756](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K200756.md) | Kubtec Mozart Supra | Kub Technologies, Inc. | Jun 12, 2020 | SESE | | [K192939](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K192939.md) | Volumetric Specimen Imager | Clarix Imaging | Dec 27, 2019 | SESE | | [K193317](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K193317.md) | CoreLite X-Ray Specimen Cabinet | Cirdan Imaging Limited | Dec 13, 2019 | SESE | | [K183624](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K183624.md) | Kubtec Mozart (Xpert42) | Kub Technologies, Inc. | Jun 20, 2019 | SESE | | [K183142](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K183142.md) | PathVisionXL | Faxitron Bioptics, LLC | Mar 14, 2019 | SESE | | [K182727](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K182727.md) | Trident HD Specimen Radiography System | Hologic, Inc. | Jan 10, 2019 | SESE | | [K173309](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K173309.md) | Faxitron VisionCT | Faxitron Bioptics, LLC | May 9, 2018 | SESE | | [K170786](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K170786.md) | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | Jul 18, 2017 | SESE | | [K153583](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K153583.md) | BioVision Plus | Faxitron Bioptics, LLC | Apr 1, 2016 | SESE | | [K122428](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K122428.md) | FAXITRON SPECIEN RADIOGRAPHY SYSTEM | Faxitron Bioptics, LLC | Sep 25, 2012 | SESE | | [K111508](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K111508.md) | TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 | Hologic, Inc. | Aug 19, 2011 | SESE | | [K091928](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K091928.md) | 10 X 10 VISION | Bioptics, Inc. | Jun 16, 2010 | SESE | | [K091558](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP/K091558.md) | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM | Bioptics, Inc. | Jul 17, 2009 | SESE | ## Top Applicants - Kub Technologies, Inc. — 6 clearances - Faxitron Bioptics, LLC — 5 clearances - Bioptics, Inc. — 4 clearances - Compai Healthcare (Suzhou) Co.,Ltd — 2 clearances - Faxitron X-Ray Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MWP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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