MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager)
Radiology · 21 CFR 892.1680 · Class 2
Overview
| Product Code | MQB |
|---|---|
| Device Name | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Regulation | 21 CFR 892.1680 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 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.
Cleared Devices (421)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | Oct 9, 2025 | SESE |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Jul 22, 2025 | SESE |
| K250665 | SKR 3000 | Konica Minolta, Inc. | Jun 17, 2025 | SESE |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | Apr 18, 2025 | SESE |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | Mar 20, 2025 | SESE |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | Mar 19, 2025 | SESE |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | Mar 18, 2025 | SESE |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | Feb 24, 2025 | SESE |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Dec 19, 2024 | SESE |
| K241319 | SKR 3000 | Konica Minolta, Inc. | Nov 21, 2024 | SESE |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | Nov 15, 2024 | SESE |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | Nov 12, 2024 | SESE |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | Nov 7, 2024 | SESE |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | Sep 9, 2024 | SESE |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | Mar 7, 2024 | SESE |
| K232082 | EXPD 4343S | DRTECH Corporation | Feb 13, 2024 | SESE |
| K232753 | EXPD 4343D; EXPD 3643D | DRTECH Corporation | Nov 16, 2023 | SESE |
| K230918 | MasterX 800 Series | Medicatech USA | Sep 1, 2023 | SESE |
| K232058 | YosemiteView 4343W/YosemiteView 3643W | Careray Digital Medical Technology Co., Ltd. | Aug 3, 2023 | SESE |
| K231959 | EXPD 4357; EXPD 4357P | DRTECH Corporation | Aug 1, 2023 | SESE |
| K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | Radmedix, LLC | Jul 12, 2023 | SESE |
| K231467 | 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF | Rayence Co., Ltd. | Jun 21, 2023 | SESE |
| K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | Mar 6, 2023 | SESE |
| K230175 | Digital Radiography CXDI-CS01 | Canon, Inc. | Feb 15, 2023 | SESE |
| K230059 | Digital Flat Panel Detector | Ray Imaging Technology (Haining) Limited | Feb 3, 2023 | SESE |
| K223546 | 14HQ721G-B | Lg Electronics.Inc | Jan 27, 2023 | SESE |
| K223687 | X-ray Flat Panel Detectors (EverestView 4343X) | Careray Digital Medical Technology Co., Ltd. | Dec 30, 2022 | SESE |
| K223009 | Wireless/Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | Nov 27, 2022 | SESE |
| K223124 | EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG | DRTECH Corporation | Nov 18, 2022 | SESE |
| K223267 | SKR 3000 | Konica Minolta, Inc. | Nov 17, 2022 | SESE |
| K222886 | Mercu 1717V | Iray Technology Taicang , Ltd. | Oct 20, 2022 | SESE |
| K222855 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | Oct 17, 2022 | SESE |
| K222687 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | Sep 29, 2022 | SESE |
| K222661 | Digital Radiography CXDI-CS01 | Canon, Inc. | Sep 27, 2022 | SESE |
| K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | Vieworks Co., Ltd. | Sep 13, 2022 | SESE |
| K221549 | X-ray Flat Panel Detectors (CareView 1800 RF) | Careray Digital Medical Technology Co., Ltd. | Aug 1, 2022 | SESE |
| K221461 | 10HQ701G-B | Lg Electronics.Inc | Jul 22, 2022 | SESE |
| K221394 | 14HQ701G-B | Lg Electronics.Inc | Jul 22, 2022 | SESE |
| K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | Vieworks Co., Ltd. | Jul 20, 2022 | SESE |
| K221876 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | Jul 15, 2022 | SESE |
| K221434 | 17HQ701G-B | Lg Electronics.Inc | Jul 13, 2022 | SESE |
| K221714 | Flat Panel Detector | Iray Technology Taicang , Ltd. | Jun 29, 2022 | SESE |
| K221345 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Jun 16, 2022 | SESE |
| K221620 | Digital Radiography CXDI-Elite, Digital Radiography E1 | Canon, Inc. | Jun 14, 2022 | SESE |
| K221144 | PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG | Radisen Co., Ltd. | May 13, 2022 | SESE |
| K220559 | 17HQ901G-B | Lg Electronics.Inc | May 5, 2022 | SESE |
| K220536 | Digital flat panel detector | Iray Technology Taicang , Ltd. | Apr 28, 2022 | SESE |
| K220510 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | Apr 14, 2022 | SESE |
| K220668 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Apr 1, 2022 | SESE |
| K213646 | Focus HD 35 Detector | Iray Technology Taicang , Ltd. | Mar 29, 2022 | SESE |
| K213529 | Focus HD 43 Detector | Iray Technology Taicang , Ltd. | Mar 29, 2022 | SESE |
| K214044 | 14HQ901G-B | Lg Electronics.Inc | Feb 16, 2022 | SESE |
| K220098 | Digital Radiography CXDI-Pro, Digital Radiography D1 | Canon, Inc. | Feb 4, 2022 | SESE |
| K213908 | SKR 3000 | Konica Minolta, Inc. | Jan 31, 2022 | SESE |
| K213780 | DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 | Canon, Inc. | Jan 24, 2022 | SESE |
| K214030 | Universal DR 1748 | Konica Minolta Healthcare Americas, Inc. | Jan 21, 2022 | SESE |
| K213307 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | Jan 14, 2022 | SESE |
| K213469 | VALORY | Agfa N.V. | Nov 18, 2021 | SESE |
| K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | Nov 15, 2021 | SESE |
| K212753 | 0909FCB, 1212FCA | Rayence Co., Ltd. | Oct 18, 2021 | SESE |
| K212269 | Intelligent NR | Canon, Inc. | Sep 17, 2021 | SESE |
| K212553 | DIGITAL RADIOGRAPHY CXDI-Pro, D1 | Canon, Inc. | Sep 9, 2021 | SESE |
| K212051 | RFA-1717DIG, RFA-1717DIC | Astel, Inc. | Aug 25, 2021 | SESE |
| K210619 | SKR 3000 | Konica Minolta, Inc. | Aug 24, 2021 | SESE |
| K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | Pzmedical Technology Co., Ltd. | Aug 23, 2021 | SESE |
| K211790 | DX-D Imaging Package with XD Detectors | Agfa N.V. | Jul 30, 2021 | SESE |
| K211542 | PRIMO S | A.T.S. Applicazione Tecnologie Speciali S.R.L. | Jul 9, 2021 | SESE |
| K211108 | Prudent 1717, Prudent 1417, Prudent 1212 | Pixxgen Corporation | Jun 4, 2021 | SESE |
| K210919 | AcuityDRe | Radmedix, LLC | Apr 30, 2021 | SESE |
| K210985 | 1717FCC | Rayence Co., Ltd. | Apr 28, 2021 | SESE |
| K210988 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | Apr 21, 2021 | SESE |
| K202441 | Eclipse II with Smart Noise Cancellation | Carestream Health, Inc. | Apr 2, 2021 | SESE |
| K203703 | I-Q View | First Source, Inc. | Mar 24, 2021 | SESE |
| K203188 | ADD | H&abyz Co., Ltd. | Mar 12, 2021 | SESE |
| K210316 | Mars 1417X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Mar 3, 2021 | SESE |
| K210314 | Mars1717X Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Mar 2, 2021 | SESE |
| K202995 | X-ray Flat Panel Detectors/CareView 3600RF | Careray Digital Medical System Co., Ltd. | Feb 19, 2021 | SESE |
| K203849 | General Radiography CXDI-CS01 | Canon, Inc. | Jan 26, 2021 | SESE |
| K203159 | Lux 35 Detector | Carestream Health | Dec 2, 2020 | SESE |
| K202722 | 1212FCA | Rayence Co., Ltd. | Oct 26, 2020 | SESE |
| K201528 | Yushan X-Ray Flat Panel Detector with DROC | Innocare Optoelectronics Corp. | Oct 11, 2020 | SESE |
| K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | Sep 30, 2020 | SESE |
| K201591 | Flat Panel Detector | Ka Imaging, Inc. | Sep 3, 2020 | SESE |
| K201932 | X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) | Careray Digital Medical System Co., Ltd. | Aug 7, 2020 | SESE |
| K201796 | 1717SCV, 1717SGV | Rayence Co., Ltd. | Jul 23, 2020 | SESE |
| K201503 | Edge Air(1417) Digital Flat Panel X-ray Detector | Osko, Inc. | Jun 29, 2020 | SESE |
| K201247 | Intraoral Sensor | Dentium Co., Ltd (Ict Branch) | Jun 10, 2020 | SESE |
| K201043 | Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) | Iray Technology Taicang , Ltd. | May 12, 2020 | SESE |
| K201058 | Accuvue+ | Radmedix, LLC | May 6, 2020 | SESE |
| K201004 | Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W | Iray Technology Taicang , Ltd. | May 1, 2020 | SESE |
| K200787 | BSD3543W | Bontech Co., Ltd. | Apr 23, 2020 | SESE |
| K200668 | DR-ID 1200SDK System | Fujifilm Corporation | Apr 10, 2020 | SESE |
| K200622 | Focus 43C detector, TRIMAX 43C detector | Iray Technology Taicang , Ltd. | Apr 1, 2020 | SESE |
| K200418 | VIVIX-S VW | Vieworks Co., Ltd. | Mar 18, 2020 | SESE |
| K192894 | Vita Flex CR System with LLI | Carestream Health, Inc. | Feb 18, 2020 | SESE |
| K193644 | E-COM DR-2000 DR | Livermoretech, Inc. | Feb 14, 2020 | SESE |
| K200018 | HAD1717MC | H&Abyz | Jan 31, 2020 | SESE |
| K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | Varex Imaging Corporation | Dec 20, 2019 | SESE |
| K193173 | CareView 1800Le | Careray Digital Medical System Co., Ltd. | Dec 13, 2019 | SESE |
| K193031 | EXPD 4343P, EXPD 3643P | DRTECH Corporation | Nov 22, 2019 | SESE |
| K193017 | EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP | DRTECH Corporation | Nov 22, 2019 | SESE |
| K192932 | FDR D-EVO III flat panel detector system | Fujifilm Corporation | Nov 12, 2019 | SESE |
| K192632 | DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless | Canon, Inc. | Nov 7, 2019 | SESE |
| K192440 | FDR SE Lite | Fujifilm Corporation | Nov 1, 2019 | SESE |
| K192512 | Focus 35C Detector, Trimax 35C Detector | Iray Technology Taicang , Ltd. | Oct 16, 2019 | SESE |
| K192400 | EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG | DRTECH Corporation | Oct 3, 2019 | SESE |
| K191939 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | Aug 29, 2019 | SESE |
| K191645 | SKR 4000 | Konica Minolta, Inc. | Aug 16, 2019 | SESE |
| K190611 | VIVIX-S 1751S | Vieworks Co., Ltd. | Apr 8, 2019 | SESE |
| K190691 | Pixx2430 Digital Diagnostic X-Ray Receptor Panel | Pixxgen Corporation | Apr 4, 2019 | SESE |
| K190368 | Enhanced Feature Software Pack CXDI Series | Canon, Inc. | Mar 13, 2019 | SESE |
| K190311 | BIOK7600 Flat Panel Detector | Biokinemetrics, Inc. | Mar 13, 2019 | SESE |
| K190300 | BIOK7600W Wireless Flat Panel Detector | Biokinemetrics, Inc. | Mar 13, 2019 | SESE |
| K190146 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | Mar 8, 2019 | SESE |
| K183245 | Carestream DRX-1 System with DRX Plus 2530 Detectors | Carestream Health, Inc. | Feb 8, 2019 | SESE |
| K183474 | Carestream DRX-1 System with DRX Core Detectors | Carestream Health, Inc. | Jan 16, 2019 | SESE |
| K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | Jan 11, 2019 | SESE |
| K183713 | Wireless Digital Flat Detector | Iray Technology Taicang , Ltd. | Jan 9, 2019 | SESE |
| K183422 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Jan 9, 2019 | SESE |
| K182688 | SKR 3000 | Konica Minolta, Inc. | Dec 18, 2018 | SESE |
| K183286 | 17HK701G-W | Lg Electronics.Inc | Dec 7, 2018 | SESE |
| K183212 | Nexus DR Digital X-ray Imaging System with stitching | Varex Imaging Corporation | Dec 7, 2018 | SESE |
| K182348 | 14HK701G-W | Lg Electronics.Inc | Oct 18, 2018 | SESE |
| K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Oct 17, 2018 | SESE |
| K182550 | Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. | Oct 17, 2018 | SESE |
| K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | Oct 4, 2018 | SESE |
| K181631 | GR40CW | Samsung Electronics Co., Ltd. | Jul 20, 2018 | SESE |
| K181565 | Aquarius 8600 Digital Radiography Sensor | Biokinemetrics, Inc. | Jul 13, 2018 | SESE |
| K181526 | XRpad2 4343 HWC-M Flat Panel Detector | Varex Imaging Corporation | Jul 3, 2018 | SESE |
| K180809 | Eclipse II | Carestream Health, Inc. | Jun 21, 2018 | SESE |
| K180989 | PEDRA-17F Digital Flat Panel X-ray Detector | Radisen, Inc. | Jun 13, 2018 | SESE |
| K180332 | 17HK700G-W | Lg Electronics | Jun 8, 2018 | SESE |
| K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | May 24, 2018 | SESE |
| K181003 | VIVIX-S 1717V | Vieworks Co., Ltd. | May 15, 2018 | SESE |
| K180667 | SmartGrid | Carestream Health, Inc. | Apr 13, 2018 | SESE |
| K171270 | DIGITAL RADIOGRAPHY CXDI-410C WIRELESS | Canon, Inc. | Nov 17, 2017 | SESE |
| K173273 | Aquarius 8600 1417WCI; Aquarius 8600 1717WCI | Imaging Dynamics Company , Ltd. | Nov 9, 2017 | SESE |
| K172124 | Televere Podiatry Digital Imaging System | Televere Systems | Nov 9, 2017 | SESE |
| K172951 | Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) | Varex Imaging Corporation | Oct 24, 2017 | SESE |
| K172784 | DX-D Imaging Package | Agfa Healthcare N.V. | Oct 13, 2017 | SESE |
| K172435 | Galaxy R Digital Radiography Upgrade | Medien International Co, Ltd. | Oct 13, 2017 | SESE |
| K172793 | SKR 3000 | Konica Minolta, Inc. | Oct 12, 2017 | SESE |
| K171169 | Aquarius 8600 1417TG and Aquarius 8600 1717TG | Imaging Dynamics Company , Ltd. | Oct 12, 2017 | SESE |
| K172682 | Edge Digital Flat Panel X-ray Detector | Osko, Inc. | Oct 6, 2017 | SESE |
| K172681 | Edge Air Digital Flat Panel X-ray Detector | Osko, Inc. | Oct 6, 2017 | SESE |
| K171175 | Aquarius 8600 1417WC | Imaging Dynamics Company , Ltd. | Oct 5, 2017 | SESE |
| K172581 | CareView 1800Cw X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | Sep 26, 2017 | SESE |
| K171716 | SKR 3000 | Konica Minolta, Inc. | Aug 25, 2017 | SESE |
| K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Philips Medical Systems Dmc GmbH | Jul 7, 2017 | SESE |
| K170480 | Models 3543A, 4343A, 2929A and A843B | Shanghai PZ Medical Technolgoy Co., Ltd. | Jul 7, 2017 | SESE |
| K163624 | Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) | Fujifilm Medical Systems U.S.A, Inc. | Jun 30, 2017 | SESE |
| K171485 | BSD4343R Digital Flat Panel X-ray Detector | Bontech, Inc. | Jun 21, 2017 | SESE |
| K171418 | 1417WCC_127um and1417WCC_140um | Rayence Co., Ltd. | Jun 12, 2017 | SESE |
| K171417 | 1417WGC_127um and 1417WGC_140um | Rayence Co., Ltd. | Jun 12, 2017 | SESE |
| K171420 | 1717SCC_127um and 1717SCC_140um | Rayence Co., Ltd. | Jun 9, 2017 | SESE |
| K171419 | 1717SGC_127um and 1717SGC_140um | Rayence Co., Ltd. | Jun 9, 2017 | SESE |
| K171138 | Nexus DR Digital X-ray Imaging System | Varex Imaging Corporation | May 17, 2017 | SESE |
| K171137 | EVS 2430W, EVS 2430GW | DRTECH Corporation | May 15, 2017 | SESE |
| K171085 | GMR40 | Neurologica Corporation, A Subsidiary OF | May 11, 2017 | SESE |
| K170975 | Televere Digital Imaging System | Televere Systems | May 1, 2017 | SESE |
| K163157 | SmartGrid | Carestream Health | Mar 21, 2017 | SESE |
| K170332 | DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS | Canon, Inc. | Mar 1, 2017 | SESE |
| K170202 | Aquarius 8600 | Imaging Dynamics Company , Ltd. | Feb 22, 2017 | SESE |
| K170113 | pixium 4343RCE | Philips Medical Systems Dmc GmbH | Feb 9, 2017 | SESE |
| K163703 | VIVIX-S 1417N | Vieworks Co., Ltd. | Feb 8, 2017 | SESE |
| K162909 | CSX-30 Flat Panel Detector | Canon, Inc. Medical Equipment Group | Jan 27, 2017 | SESE |
| K162555 | EVS 4343, EVS 4343G | DRTECH Corporation | Dec 21, 2016 | SESE |
| K162344 | INNOLUX RIC | Innolux Corporation | Dec 20, 2016 | SESE |
| K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai) , Ltd. | Dec 8, 2016 | SESE |
| K162552 | EVS 3643, EVS 3643G | DRTECH Corporation | Dec 2, 2016 | SESE |
| K163019 | CareView 750Cw/750C X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | Dec 1, 2016 | SESE |
| K160143 | ClearVision ExamVue Flat Panel Detector | Jpi Healthcare, Inc. | Oct 28, 2016 | SESE |
| K162487 | BSD3543 Digital Flat Panel X-ray Detector | Bontech, Inc. | Oct 14, 2016 | SESE |
| K162519 | 1717WCC / 1717WGC | Rayence Co., Ltd. | Oct 6, 2016 | SESE |
| K162518 | 1012WCC, 1012WGC | Rayence Co., Ltd. | Oct 6, 2016 | SESE |
| K162504 | SKR 3000 | Konica Minolta, Inc. | Oct 3, 2016 | SESE |
| K161368 | DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s) | Agfa Healthcare N.V. | Sep 22, 2016 | SESE |
| K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | Perkinelmer, Inc. | Sep 8, 2016 | SESE |
| K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | Varian Medical Systems, X-Ray Products-Infimed | Sep 6, 2016 | SESE |
| K162178 | CareView 1500P X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | Sep 1, 2016 | SESE |
| K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | Perkinelmer, Inc. | Sep 1, 2016 | SESE |
| K153312 | SCATTER CORRECTION FOR CXDI SERIES | Canon, Inc. | Jun 28, 2016 | SESE |
| K160204 | BSD4343 Digital Flat Panel X-ray Detector | Bontech, Inc. | Jun 9, 2016 | SESE |
| K160810 | ViZion DR + Wireless | Viztek, LLC | May 20, 2016 | SESE |
| K153464 | FDR D-EVO flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | Apr 8, 2016 | SESE |
| K153710 | Tuxedo Digital Dental Sensor | Led Dental, Inc. | Mar 18, 2016 | SESE |
| K152894 | VIVIX-S 1717N | Vieworks Co., Ltd. | Feb 26, 2016 | SESE |
| K152855 | VIVIX-S 1012N | Vieworks Co., Ltd. | Feb 26, 2016 | SESE |
| K153492 | CareView 1800L | Careray Digital Medical System Co., Ltd. | Dec 24, 2015 | SESE |
| K153318 | Philips Eleva Workspot with SkyFlow | Philips Medical Systems Dmc GmbH | Dec 22, 2015 | SESE |
| K153401 | GR40CW | Samsung Electronics Co., Ltd. | Dec 21, 2015 | SESE |
| K152639 | DR 600 | Agfa Healthcare N.V. | Dec 11, 2015 | SESE |
| K153142 | Carestream DRX-1 System with DRX Plus 4343 Detectors | Carestream Health, Inc. | Nov 25, 2015 | SESE |
| K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors | Careray Digital Medical System Co., Ltd. | Nov 10, 2015 | SESE |
| K152151 | ATAL 9 | Atlaim Corporation | Nov 10, 2015 | SESE |
| K152138 | FDR D-EVO GL Flat Panel Detector System | Fujifilm Medical System U.S.A., Inc. | Nov 5, 2015 | SESE |
| K151942 | EVS 3643 | DRTECH Corporation | Oct 21, 2015 | SESE |
| K152094 | GR40CW | Samsung Electronics Co., Ltd. | Oct 16, 2015 | SESE |
| K152279 | ViZion DR + Wireless | Viztek, LLC | Sep 10, 2015 | SESE |
| K141488 | CAREVIEW 1800R | Careray Digital Medical System Co., Ltd. | Sep 8, 2015 | SESE |
Top Applicants
- Rayence Co., Ltd. — 28 clearances
- Canon, Inc. — 27 clearances
- Iray Technology Taicang , Ltd. — 17 clearances
- DRTECH Corporation — 14 clearances
- Vieworks Co., Ltd. — 13 clearances
