System, X-Ray, Fluoroscopic, Image-Intensified
Regulation 892.1650
1510(k)s in 12 months (300 all time)
4recalls in 12 months (223 all time)
197recalls that name a 510(k)
Top companies in JAA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2025 | Philips North America Azurion R3.0.
Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM Open, Classified |
JAA | K200917 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH Precision CRF;
Model Number: 706400; Open, Classified |
JAA | K233945 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH CombiDiagnost R90;
Model Number: 709031; Open, Classified |
JAA | K232910 |
| Nov 7, 2025 | Philips Medical Systems DMC GmbH ProxiDiagnost N90;
Model Number: 706110; Open, Classified |
JAA | K233945 |
| Jun 17, 2025 | Siemens Medical Solutions USA, Inc UROSKOP Omnia Max. Model Number: 10762473 Open, Classified |
JAA | K101491 K173639 |
| Jun 17, 2025 | Siemens Medical Solutions USA, Inc UROSKOP Omnia. Model Number: 10094910 Open, Classified |
JAA | K101491 K173639 |
| Nov 7, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION The FLUOROspeed is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a flat detector, it can perform a range of applications including gener Open, Classified |
JAA | K191877 |
| Nov 7, 2024 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radiography and pediatric examinations, excluding mammo Open, Classified |
JAA | K190373 |
| Aug 27, 2024 | Agfa N.V. DR 800. Digital Radiography X-ray System. Open, Classified |
JAA | K180589 K183275 |
| Feb 14, 2024 | PHILIPS MEDICAL SYSTEMS CombiDiagnost R90 1.1 (709031) Open, Classified |
JAA | K203087 |
| Feb 14, 2024 | PHILIPS MEDICAL SYSTEMS CombiDiagnost R90 1.0 (709030) Open, Classified |
JAA | K163210 |
| Feb 9, 2024 | Philips North America ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Ref:706150 Open, Classified |
JAA | K212837 |
| Feb 9, 2024 | Philips North America ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system
Ref:
(1)706100
(2)706110 Open, Classified |
JAA | K212837 |
| Nov 8, 2023 | Philips North America Llc ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system Open, Classified |
JAA | K212837 |
| Nov 8, 2023 | Philips North America Llc EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K031535 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K210692 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K210692 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K202564 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K202564 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K210692 |
| Nov 8, 2023 | Philips North America Llc DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images. Open, Classified |
JAA | K210692 |
| Nov 8, 2023 | Philips North America Llc CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system Open, Classified |
JAA | K203087 |
| May 15, 2023 | Philips North America CombiDiagnost R90 R1.1 Open, Classified |
JAA | K203087 |
| May 15, 2023 | Philips North America CombiDiagnost R90 R.1.0 Open, Classified |
JAA | K163210 |
| May 15, 2023 | Philips North America ProxiDiagnost N90 R.1.0 Open, Classified |
JAA | K173433 |
| Apr 10, 2023 | Philips North America Llc ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110 Open, Classified |
JAA | K163210 K173433 |
| Apr 10, 2023 | Philips North America Llc CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031 Open, Classified |
JAA | K163210 K203087 |
| Jan 20, 2023 | Siemens Medical Solutions USA, Inc AXIOM Luminos Agile Open, Classified |
JAA | K111292 |
| Oct 21, 2022 | Siemens Medical Solutions USA, Inc ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 Open, Classified |
JAA | K163286 |
| Jul 12, 2022 | Philips Medical Systems DMC GmbH ProxiDiagnost N90. radiography and fluoroscopy system Open, Classified |
JAA | K212837 |
| Jun 27, 2022 | Siemens Medical Solutions USA, Inc Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000 Open, Classified |
JAA | K201156 |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY TV SYSSTEM SONIALVISION safire17 Open, Classified |
JAA | K190373 |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY TV SYSTEM SONIALVISION G4 Open, Classified |
JAA | K142341 |
| Jan 10, 2022 | Shimadzu Medical Systems MODEL: X-RAY R/F SYSTEM FLUOROspeed X1 Open, Classified |
JAA | K191877 |
| Sep 24, 2021 | Philips North America Llc Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, Terminated |
JAA | K181830 |
| Sep 22, 2021 | Philips Healthcare CombiDiagnost R90 is multi-functional general R/F systems. Open, Classified |
JAA | K203087 |
| Dec 10, 2020 | GE Healthcare, LLC GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjec Terminated |
JAA | K133553 |
| Sep 9, 2020 | Siemens Medical Solutions USA, Inc Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal inva Terminated |
JAA | K173639 |
| Sep 9, 2020 | Siemens Medical Solutions USA, Inc Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive Terminated |
JAA | K101491 |
| Jul 22, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost R90
Software Version R1.0 and R1.1 Open, Classified |
JAA | K203087 |
| Jul 10, 2020 | Philips North America, LLC EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. Terminated |
JAA | K031535 |
| Apr 23, 2020 | Philips North America, LLC ProxiDiagnost N90, UDI 706100 Terminated |
JAA | K173433 |
| Apr 6, 2020 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoros Terminated |
JAA | K180589 |
| Mar 5, 2020 | Philips North America, LLC Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079
Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vasc Terminated |
JAA | K181830 |
| Feb 20, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Terminated |
JAA | K163210 |
| Feb 20, 2020 | Philips Medical Systems Gmbh, DMC CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. Terminated |
JAA | K163210 |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Uroskop Omnia max
Model: 10762473 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
JAA | K173639 |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Luminos Agile Max
Model: 10762472 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
JAA | K173639 |
| Jan 8, 2020 | Siemens Medical Solutions USA, Inc SIEMENS Healthineers Luminos dRF Max
Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Terminated |
JAA | K173639 |
| Jun 27, 2019 | Agfa N.V. AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Product Usage:
The Agfa s DR 800 system is indicated for performing dynamic imaging examinations (fluoroscopy and/or rapid sequence) Terminated |
JAA | K180589 |
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