System, X-ray, Angiographic

Product Code: IZI

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: 892.1600


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as IZI

5342System, X-ray, AngiographicAngiographic X-ray System.

Total Product Life Cycle (TPLC) Devices

5342System, X-ray, AngiographicAngiographic X-ray System.

FDA Consensus Standards

System, X-Ray, Angiographic [37593]21 CFR §892.1600 🔎
System, X-Ray, Angiographic [37630]21 CFR §892.1600 🔎
System, X-Ray, Angiographic [32778]21 CFR §892.1600 🔎

Pre-market Notifications for IZI

K214097Explorer Air IISurgVision GmbH
K202391DIR 800Aesculap, Inc.
K192761Asimov-MKS Imaging SystemOnLume Inc.
K190772SURGICAL MICROSCOPE SYSTEM ORBEYE With IROLYMPUS MEDICAL SYSTEMS CORP.
K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies ULC. (now A Part Of Stryker)
K181537GLOW800Leica Microsystems (Schweiz) AG
K180019CAAS WorkstationPie Medical Imaging BV
K170239Leica FL560LEICA MICROSYSTEMS (SCHWEIZ) AG
K162991YELLOW 560 Fluorescence ModuleCarl Zeiss Meditec AG
K151780CAAS WorkstationPIE MEDICAL IMAGING B.V.
K141136LEICA FL800LEICA BIOSYSTEMS RICHMOND
K133993CAAS WORKSTATIONPIE MEDICAL IMAGING
K133719PDE-NEOHAMAMATSU PHOTONICS, K.K.
K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K130003XIRALITE FLOURESCENCE IMAGING SYSTEM X4MIVENION GMBH

Global Unique Device Identification Database

50749756627288System, x-ray, angiographic
50749756627271System, x-ray, angiographic
50749756627264System, x-ray, angiographic
50749756627240System, x-ray, angiographic
50749756616725System, x-ray, angiographic
50749756324019System, x-ray, angiographic
50749756323975System, x-ray, angiographic
50749756323791System, x-ray, angiographic
50749756323777System, x-ray, angiographic
50749756323753System, x-ray, angiographic
50749756281770System, x-ray, angiographic
50749756247868System, x-ray, angiographic
00886874110881System, x-ray, angiographic
00886874110447System, x-ray, angiographic
00886874110218System, x-ray, angiographic

Maude Adverse Events

ALLURA XPER FD10PHILIPS HEALTHCARE2020-01-21
ALLURA XPER FD10PHILIPS HEALTHCARE2019-11-27
ALLURA XPER FD10PHILIPS HEALTHCARE2019-11-26
ALLURA XPER FD10/10PHILIPS HEALTHCARE2019-11-08
ALLURA XPER FD10PHILIPS HEALTHCARE2019-10-08
ALLURA XPER FD10/10PHILIPS HEALTHCARE2019-10-02
NAMIC SQUEEZE CONTRAST CONTROLLERANGIODYNAMICS, INC.2019-09-09
PHILIPS ALLURA XPER FD20PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2019-08-16
ALLURA XPER FD10/10PHILIPS HEALTHCARE2019-07-23
ALLURA XPER FD10PHILIPS HEALTHCARE2019-07-18
ALLURA XPER FD10PHILIPS HEALTHCARE2019-07-12
ALLURA XPER FD10PHILIPS HEALTHCARE2019-06-07
ALLURA XPER FD10PHILIPS HEALTHCARE2019-06-06
ULTIMAXCANON MEDICAL SYSTEMS CORPORATION2019-05-24
ALLURA XPER FD10PHILIPS HEALTHCARE2019-05-15
SIEMENS ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-04-19
ARTIS Q BIPLANESIEMENS HEALTHCARE GMBH2019-04-19
SPY ELITE DRUG DRAPE KIT (SPY PAQ)NOVADAQ TECHNOLOGIES2019-04-18
ALLURA XPER FD10PHILIPS HEALTHCARE2019-04-17
ALLURA XPER FD10PHILIPS HEALTHCARE2019-04-08
ALLURA XPER FD10PHILIPS HEALTHCARE2019-03-29
ALLURA XPER FD10 CPHILIPS HEALTHCARE2019-03-05
ALLURA XPER FD10 CPHILIPS HEALTHCARE2019-03-05
ALLURA XPER FD10 CPHILIPS HEALTHCARE2019-03-05
ALLURA XPER FD10/10 OR TABLEPHILIPS HEALTHCARE2019-02-22
INTEGRIS ALLURA 9PHILIPS HEALTHCARE2019-01-04
ALLURA XPER FD10PHILIPS HEALTHCARE2018-12-21
ALLURA XPER FD10PHILIPS HEALTHCARE2018-12-21
ALLURA XPER FD10PHILIPS HEALTHCARE2018-12-18
ALLURA XPER FD10PHILIPS HEALTHCARE2018-12-06
2018-10-29
AXIOM ARTIS ZEESIEMENS AG/SIEMENS HEALTHCARE GMBH2018-10-26
INTEGRIS CV (CESAR-POWERPACK-VISUB-NICOL)PHILIPS HEALTHCARE2018-10-23
INTEGRIS ALLURA 9 BIPLANEPHILIPS HEALTHCARE2018-09-25
AXIOM ARTISSIEMENS MEDICAL SOLUTIONS USA, INC2018-08-13
ALLURA XPER FD10PHILIPS HEALTHCARE2018-07-25
ARTIS ZEE FLOORSIEMENS MEDICAL SOLUTIONS USA INC.2018-06-14
SPY ELITE WITH SPY-QSTRYKER ENDOSCOPY-SAN JOSE2018-05-02
PHILIPS X-RAYPHILIPS MEDICAL SYSTEMS INC.2018-05-02
ALLURA XPER FD10PHILIPS HEALTHCARE2018-04-30
ARTIS ZEE CEILINGSIEMENS HEALTHCARE GMBH2018-04-09
ARTIS ZEEGOSIEMENS HEALTHCARE GMBH2018-04-09
ALLURA XPER FD10PHILIPS HEALTHCARE2018-04-09
ARTIS ZEEGOSIEMENS HEALTHCARE GMBH2018-04-06
ARTIS ZEE CEILINGSIEMENS HEALTHCARE GMBH2018-04-05
ARTIS ZEEGOSIEMENS HEALTHCARE GMBH2018-04-04
ARTIS ZEE BIPLANESIEMENS HEALTHCARE GMBH2018-03-19
ARTIS ZEE BIPLANESIEMENS HEALTHCARE GMBH2018-03-19
ARTIS ZEEGOSIEMENS HEALTHCARE GMBH2018-03-19
ARTIS ZEE CEILINGSIEMENS HEALTHCARE GMBH2018-03-09
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