Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation 892.1680
3510(k)s in 12 months (424 all time)
2recalls in 12 months (195 all time)
193recalls that name a 510(k)
Top companies in MQB
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | Philips North America Llc DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. Open, Classified |
MQB | K202564 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER;
Model Number: (1) 712034, (2) 712035; Open, Classified |
MQB | K202564 |
| Jun 30, 2023 | Philips North America Llc DigitalDiagnost C90, Model No. 712034 and 712035 Open, Classified |
MQB | K202564 |
| Sep 22, 2021 | Philips Healthcare DigitalDiagnost C90 Open, Classified |
MQB | K202564 |
| Mar 11, 2021 | LIEBEL-FLARSHEIM COMPANY LLC HydraVision Digital Imaging System
Product ID/Reorder Number: 705559 (65KW) Terminated |
MQB | K121838 |
| Feb 5, 2021 | Canon Medical System, USA, INC. System INFX-8000F Open, Classified |
MQB | K081624 |
| Dec 8, 2020 | Canon Medical System, USA, INC. Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F
Catheterization Table CAT-880B
Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ang Open, Classified |
MQB | K081624 |
| Apr 6, 2020 | Siemens Medical Solutions USA, Inc System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radio Terminated |
MQB | K061054 |
| Mar 3, 2020 | Canon Medical System, USA, INC. Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration Open, Classified |
MQB | K081624 |
| Jan 7, 2020 | Palodex Group Oy Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Jan 7, 2020 | Palodex Group Oy KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Jan 7, 2020 | Palodex Group Oy Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Jan 7, 2020 | Palodex Group Oy Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) Terminated |
MQB | K041050 |
| Feb 8, 2019 | Canon Medical System, USA, INC. Infinix DP- i(Infinix-8000F) CAT-870B Catheterization Table (Titling) - Product Usage: The catheterization table is used with Infinix-8000F System (Interventional Angiography System), to position pati Terminated |
MQB | K081624 |
| Jan 8, 2019 | Swissray Medical AG ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version)
The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of Terminated |
MQB | K050718 |
| Nov 2, 2018 | Virtual Imaging, Inc. RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C
Product Usage:
Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremiti Terminated |
MQB | K101517 |
| Oct 16, 2018 | Canon Medical System, USA, INC. Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005
Product Usage:
The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which Terminated |
MQB | K122842 |
| Sep 19, 2018 | Philips Medical Systems Gmbh, DMC Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System
Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228. Terminated |
MQB | K141736 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC EasyDiagnost Eleva DRF (Stitching Patient Support) 706032 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Upgrades (Stitching Patient Support) 712083 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Single Detector (Stitching Patient Support) 712020 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3 (Stitching Patient Support) 712025 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Dual Detector (Stitching Patient Support) 712022 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 High Performance
(Stitching Patient Support) 712031 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 Flex / Value (Stitching Patient Support) 712028 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 (Stitching Patient Support) 712225 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC CombiDiagnost R90 (Stitching Patient Support) 709030 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC BuckyDiagnost Ceiling System (Stitching Patient Support) 704031 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost Release 3 (Stitching Patient Support) 712025 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 4 Flex / Value
(Stitching Patient Support) 712028 Terminated |
MQB | K090625 |
| Aug 17, 2018 | Philips Medical Systems Gmbh, DMC DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082 Terminated |
MQB | K090625 |
| Jul 18, 2018 | Sedecal S.A. Sedecal NOVA FA DR System. for diagnostic radiography. Open, Classified |
MQB | K133782 |
| May 9, 2018 | Konica Minolta Medical Imaging USA, Inc. CS-7, Model No. A4C1 Terminated |
MQB | K151465 |
| Apr 18, 2018 | Canon Medical System, USA, INC. DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) Terminated |
MQB | K122842 |
| Jan 12, 2018 | NeuroLogica Corporation Solid state x-ray imager (flat panel/digital imager)
Solid state x-ray imager (flat panel/digital imager)
Medical Terminated |
MQB | K171085 |
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