ClearanceBrief
Panels › Radiology › Product code JAA · Class 2

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)
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Top companies in JAA

DateFirm and productCodeLinked 510(k)
Dec 9, 2025Philips North America
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Open, Classified
JAAK200917
Nov 7, 2025Philips Medical Systems DMC GmbH
Precision CRF; Model Number: 706400;
Open, Classified
JAAK233945
Nov 7, 2025Philips Medical Systems DMC GmbH
CombiDiagnost R90; Model Number: 709031;
Open, Classified
JAAK232910
Nov 7, 2025Philips Medical Systems DMC GmbH
ProxiDiagnost N90; Model Number: 706110;
Open, Classified
JAAK233945
Jun 17, 2025Siemens Medical Solutions USA, Inc
UROSKOP Omnia Max. Model Number: 10762473
Open, Classified
JAAK101491
K173639
Jun 17, 2025Siemens Medical Solutions USA, Inc
UROSKOP Omnia. Model Number: 10094910
Open, Classified
JAAK101491
K173639
Nov 7, 2024SHIMADZU 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
JAAK191877
Nov 7, 2024SHIMADZU 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
JAAK190373
Aug 27, 2024Agfa N.V.
DR 800. Digital Radiography X-ray System.
Open, Classified
JAAK180589
K183275
Feb 14, 2024PHILIPS MEDICAL SYSTEMS
CombiDiagnost R90 1.1 (709031)
Open, Classified
JAAK203087
Feb 14, 2024PHILIPS MEDICAL SYSTEMS
CombiDiagnost R90 1.0 (709030)
Open, Classified
JAAK163210
Feb 9, 2024Philips North America
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Open, Classified
JAAK212837
Feb 9, 2024Philips North America
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Open, Classified
JAAK212837
Nov 8, 2023Philips North America Llc
ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Open, Classified
JAAK212837
Nov 8, 2023Philips North America Llc
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK031535
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK210692
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK210692
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK202564
Nov 8, 2023Philips North America Llc
DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK202564
Nov 8, 2023Philips North America Llc
DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK210692
Nov 8, 2023Philips North America Llc
DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Open, Classified
JAAK210692
Nov 8, 2023Philips North America Llc
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Open, Classified
JAAK203087
May 15, 2023Philips North America
CombiDiagnost R90 R1.1
Open, Classified
JAAK203087
May 15, 2023Philips North America
CombiDiagnost R90 R.1.0
Open, Classified
JAAK163210
May 15, 2023Philips North America
ProxiDiagnost N90 R.1.0
Open, Classified
JAAK173433
Apr 10, 2023Philips North America Llc
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Open, Classified
JAAK163210
K173433
Apr 10, 2023Philips North America Llc
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Open, Classified
JAAK163210
K203087
Jan 20, 2023Siemens Medical Solutions USA, Inc
AXIOM Luminos Agile
Open, Classified
JAAK111292
Oct 21, 2022Siemens Medical Solutions USA, Inc
ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Open, Classified
JAAK163286
Jul 12, 2022Philips Medical Systems DMC GmbH
ProxiDiagnost N90. radiography and fluoroscopy system
Open, Classified
JAAK212837
Jun 27, 2022Siemens Medical Solutions USA, Inc
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Open, Classified
JAAK201156
Jan 10, 2022Shimadzu Medical Systems
MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
Open, Classified
JAAK190373
Jan 10, 2022Shimadzu Medical Systems
MODEL: X-RAY TV SYSTEM SONIALVISION G4
Open, Classified
JAAK142341
Jan 10, 2022Shimadzu Medical Systems
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Open, Classified
JAAK191877
Sep 24, 2021Philips 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
JAAK181830
Sep 22, 2021Philips Healthcare
CombiDiagnost R90 is multi-functional general R/F systems.
Open, Classified
JAAK203087
Dec 10, 2020GE 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
JAAK133553
Sep 9, 2020Siemens 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
JAAK173639
Sep 9, 2020Siemens 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
JAAK101491
Jul 22, 2020Philips Medical Systems Gmbh, DMC
CombiDiagnost R90 Software Version R1.0 and R1.1
Open, Classified
JAAK203087
Jul 10, 2020Philips North America, LLC
EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
Terminated
JAAK031535
Apr 23, 2020Philips North America, LLC
ProxiDiagnost N90, UDI 706100
Terminated
JAAK173433
Apr 6, 2020Agfa 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
JAAK180589
Mar 5, 2020Philips 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
JAAK181830
Feb 20, 2020Philips Medical Systems Gmbh, DMC
CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Terminated
JAAK163210
Feb 20, 2020Philips Medical Systems Gmbh, DMC
CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.
Terminated
JAAK163210
Jan 8, 2020Siemens 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
JAAK173639
Jan 8, 2020Siemens 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
JAAK173639
Jan 8, 2020Siemens 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
JAAK173639
Jun 27, 2019Agfa 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
JAAK180589

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