System, X-ray, Fluoroscopic, Image-intensified

Product Code: JAA

Radiology Medical Diagnostic X-Ray Equipment

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1650


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as JAA

5352System, X-ray, Fluoroscopic, Image-intensifiedImage-intensified Fluoroscopic X-ray System.

Total Product Life Cycle (TPLC) Devices

5352System, X-ray, Fluoroscopic, Image-intensifiedImage-intensified Fluoroscopic X-ray System.

FDA Consensus Standards

System, X-Ray, Fluoroscopic, Image-Intensified [37593]21 CFR §892.1650 🔎
System, X-Ray, Fluoroscopic, Image-Intensified [37630]21 CFR §892.1650 🔎
System, X-Ray, Fluoroscopic, Image-Intensified [32778]21 CFR §892.1650 🔎
System, X-Ray, Fluoroscopic, Image-Intensified [33118]21 CFR §892.1650 🔎
System, X-Ray, Fluoroscopic, Image-Intensified [32777]21 CFR §892.1650 🔎
System, X-Ray, Fluoroscopic, Image-Intensified [37989]21 CFR §892.1650 🔎
System, X-Ray, Fluoroscopic, Image-Intensified [37990]21 CFR §892.1650 🔎

Pre-market Notifications for JAA

K212837ProxiDiagnost N90Philips Medical Systems DMC GmbH
K210469Insight Agile DRFImaging Engineering, LLC
K203428Ziehm Vision RFDZiehm Imaging GmbH
K203087CombiDiagnost R90Philips Medical Systems DMC GmbH
K203010Platinum DRF Imaging SystemApelem-DMS Group
K202235ArtPIX DRFCMT Medical Technologies Ltd
K200965XR-MX/1000KARL STORZ Endoscopy America, Inc.
K200396Insight Enhanced DRF Digital Imaging SystemImaging Engineering, LLC
K191877FLUOROspeedShimadzu Corporation
K191713CS-series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield™ (ROI Assembly)Omega Medical Imaging, LLC
K191504PowerDRRadiology Information Systems, Inc.
K191310Insight Essentials DRF Digital Imaging SystemImaging Engineering, LLC
K190373SonialVision G4SHIMADZU Corporation
K182834CS-series-FP With Optional ROI Accessory CA-100SOmega Medical Imaging, LLC
K180651Uroview FD IIPausch Medical GmbH

Global Unique Device Identification Database

30680211002799System, X-Ray, Fluoroscopic, Image-Intensified
30680211002782System, X-Ray, Fluoroscopic, Image-Intensified
00680211002774System, X-Ray, Fluoroscopic, Image-Intensified
30680211002768System, X-Ray, Fluoroscopic, Image-Intensified
30680211002751System, X-Ray, Fluoroscopic, Image-Intensified
00680211002743System, X-Ray, Fluoroscopic, Image-Intensified
30680211002737System, X-Ray, Fluoroscopic, Image-Intensified
00680211002729System, X-Ray, Fluoroscopic, Image-Intensified
00680211002712System, X-Ray, Fluoroscopic, Image-Intensified
00680211002705System, X-Ray, Fluoroscopic, Image-Intensified
00680211002699System, X-Ray, Fluoroscopic, Image-Intensified
00680211002682System, X-Ray, Fluoroscopic, Image-Intensified
30680211002676System, X-Ray, Fluoroscopic, Image-Intensified
00680211002668System, X-Ray, Fluoroscopic, Image-Intensified
00680211002651System, X-Ray, Fluoroscopic, Image-Intensified

Maude Adverse Events

LEGACY/LEGACY-D TABLEGE MEDICAL SYSTEMS, LLC2020-03-20
FIXED IMAGING EQUIPMENTSIEMENS MEDICAL SOLUTIONS USA, INC.2020-03-06
UROSKOP OMNIASIEMENS HEALTHCARE GMBH2020-03-04
AXIOM LUMINOS AGILESIEMENS HEALTHCARE GMBH2020-02-18
AXIOM LUMINOS TFSIEMENS HEALTHCARE GMBH2020-02-07
ARTIS VD 11CSIEMENS MEDICAL SOLUTIONS USA, INC.2020-02-06
GEFLUOROSCOPIC INTERVENTIONAL X-RAY SYSTEMGE HEALTHCARE2020-01-29
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIEDGE MEDICAL SYSTEMS, INC.2020-01-13
LUMINOS AGILE MAXSIEMENS HEALTHCARE GMBH2020-01-09
9900GE OEC MEDICAL SYSTEMS, INC2019-12-24
AXIOM LUMINOS AGILESIEMENS HEALTHCARE GMBH2019-11-20
PRECISION 600GE MEDICAL SYSTEMS, LLC2019-11-19
LUMINOS AGILE MAXSIEMENS HEALTHCARE GMBH2019-11-19
PRECISION 500D R&F X-RAY SYSTEMGE MEDICAL SYSTEMS, LLC2019-11-15
UROSKOP ACCESS RSIEMENS AG/SIEMENS HEALTHCARE GMBH2019-11-05
PROXIDIAGNOST N90PHILIPS MEDICAL SYSTEMS DMC GMBH2019-10-15
COMBIDIAGNOST R90PHILIPS MEDICAL SYSTEMS DMC GMBH2019-10-08
ARTIS QSIEMENS HEALTHCARE GMBH2019-10-04
BIPLANE DEVICESIEMENS HEALTHCARE GMBH2019-09-04
ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-09-03
ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-09-03
UROSKOP OMNIA MAXSIEMENS HEALTHCARE GMBH2019-09-03
IMAGING SYSTEMMEDTRONIC NAVIGATION, INC (LITTLETON)2019-08-29
COMBIDIAGNOST R90PHILIPS MEDICAL SYSTEMS DMC GMBH2019-08-12
PRECISION 500D R&F X-RAY SYSTEMGE MEDICAL SYSTEMS, LLC2019-07-29
ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-06-20
ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-06-20
LUMINOS AGILE MAXSIEMENS HEALTHCARE GMBH2019-06-19
AXIOM ICONOS R200SIEMENS HEALTHCARE GMBH2019-06-18
PRECISION 500D R&F X-RAY SYSTEMGE MEDICAL SYSTEMS, LLC2019-05-22
FLOUROSCANHOLOGIC, INC2019-05-07
EASYDIAGNOST ELEVAPHILLIPS2019-05-01
EASYDIAGNOST ELEVA2019-05-01
AXIOM ICONOS R200SIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES2019-04-29
AXIOM LUMINOS TFSIEMENS HEALTHCARE GMBH, ADVANCED THERAPIES2019-04-29
ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-04-26
AXIOM ICONOS R200SIEMENS HEALTHCARE GMBH2019-04-24
AXIOM ICONOS R200SIEMENS HEALTHCARE GMBH2019-04-24
LUMINOS AGILE MAXSIEMENS HEALTHCARE GMBH2019-04-23
UROSKOP OMNIA MAXSIEMENS HEALTHCARE GMBH2019-04-19
LUMINOS AGILE MAXSIEMENS HEALTHCARE GMBH2019-04-17
AXIOM ICONOS R200SIEMENS HEALTHCARE GMBH2019-04-15
AXIOM ICONOS R200SIEMENS HEALTHCARE GMBH2019-04-11
COMBIDIAGNOST R90PHILIPS MEDICAL SYSTEMS DMC GMBH2019-04-08
UMINOS AGILE MAXSIEMENS HEALTHCARE GMBH2019-03-28
ALLURA XPER FD20 OR TABLEPHILIPS HEALTHCARE2019-03-20
SURGICAL C-ARMGE (OEM) HEALTHCARE SURGERY2019-03-15
CANONCANON MEDICAL SYSTEMS CORPORATION2019-03-12
UROSKOP OMNIASIEMENS AG/SIEMENS HEALTHCARE GMBH2019-03-04
ARTIS QSIEMENS HEALTHCARE GMBH2019-01-29
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