System, X-ray, Stationary

Product Code: KPR

Radiology Medical Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

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: 892.1680


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as KPR

5369System, X-ray, StationaryStationary X-ray System.

Total Product Life Cycle (TPLC) Devices

5369System, X-ray, StationaryStationary X-ray System.

FDA Consensus Standards

System, X-Ray, Stationary [37593]21 CFR §892.1680 🔎
System, X-Ray, Stationary [37630]21 CFR §892.1680 🔎
System, X-Ray, Stationary [32778]21 CFR §892.1680 🔎
System, X-Ray, Stationary [33118]21 CFR §892.1680 🔎

Pre-market Notifications for KPR

K223060DigiX FDXAllengers Medical Systems Limited
K221853OTC DDRKonica Minolta Healthcare Americas, Inc
K220518SKANRAD 400Skanray Technologies Limited
K220271Hand Diagnostic Radiography Imaging SystemNanoRay Biotech Co., Ltd
K214012Straight Arm DDRKonica Minolta Healthcare Americas, Inc
K213057ExamVue DuoJPI Healthcare Co, Ltd.
K212186Philips Radiology Smart AssistantPhilips Medical Systems DMC GmbH
K210692DigitalDiagnostPhilips Medical Systems DMC GmbH
K203537Proteus XR/f, Models ST And ET, Multirad And Multirad NET Radiographic SystemsSEDECAL SA
K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.
K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.
K202572GXR-Series Diagnostic X-Ray SystemDRGEM Corporation
K202394EOSedgeEOS Imaging
K202293Radiographic System Challenge XSedecal, SA.
K202156DIAMOND-5A/6A/8ADRGEM Corporation

Global Unique Device Identification Database

00817100020490System, X-Ray, Stationary
00817100020339System, X-Ray, Stationary
00817100020209System, X-Ray, Stationary
00817100020162System, X-Ray, Stationary
00817100020155System, X-Ray, Stationary
00817100020148System, X-Ray, Stationary
00817100020131System, X-Ray, Stationary
00817100020094System, X-Ray, Stationary
00817100020070System, X-Ray, Stationary
00817100020063System, X-Ray, Stationary
00817100020056System, X-Ray, Stationary
00817100020049System, X-Ray, Stationary
00817100020032System, X-Ray, Stationary
00817100020025System, X-Ray, Stationary
00817100020018System, X-Ray, Stationary

Maude Adverse Events

AXIOM ARISTOS FX PLUSSIEMENS HEALTHCARE GMBH2020-03-27
DRX-ASCEND SYSTEMCARESTREAM HEALTH INC2020-02-18
DX-D 300AGFA N.V.2020-02-14
YSIOSIEMENS HEALTHCARE GMBH2020-02-12
MULTIX FUSIONSIEMENS MEDICAL SOLUTIONS USA, INC.2020-02-06
2020-01-27
2020-01-27
2020-01-20
2020-01-13
2020-01-13
DISCOVERY XR656 HDGE HANGWEI MEDICAL SYSTEMS CO., LTD.2020-01-09
MULTIDIAGNOST ELEVAPHILIPS HEALTHCARE2019-12-18
2019-11-26
2019-11-14
SYSTEM, X-RAY, STATIONARYSIEMENS AG/SIEMENS HEALTHCARE GMBH2019-11-07
2019-11-01
2019-11-01
2019-11-01
2019-11-01
PROTEUS XR/A RADIOGRAPHIC SYSTEMGE HANGWEI MEDICAL SYSTEMS CO., LTD.2019-10-28
DISCOVERY XR650 DIGITAL RADIOGRAPHIC IMAGING SYSTEMGE MEDICAL SYSTEMS, LLC2019-10-28
PROTEUS ANALOG XRGE MEDICAL SYSTEMS, LLC2019-10-22
RADSPEED PROSHIMADZU MEDICAL SYSTEMS2019-10-18
RADSPEED PROSHIMADZU MEDICAL SYSTEMS2019-10-18
RADSPEED PROSHIMADZU MEDICAL SYSTEMS2019-10-18
PROTEUS XR/A RADIOGRAPHIC SYSTEMGE HANGWEI MEDICAL SYSTEMS CO., LTD.2019-10-17
2019-10-15
2019-10-15
2019-10-15
GU60ASAMSUNG ELECTRONICS CO., LTD.2019-10-11
MULTIX SELECT DRSIEMENS SHANGHAI MEDICAL EQUIPMENT LTD2019-10-10
2019-10-04
2019-10-03
2019-09-09
2019-09-09
YSIO MAXSIEMENS HEALTHCARE GMBH2019-09-03
SHIMADZUSHIMADZU CORPORATION2019-08-22
DEFINIUM 8000 DIGITAL RADIOGRAPHIC IMAGING SYSTEMGE MEDICAL SYSTEMS, LLC2019-08-21
MULTIX IMPACTSIEMENS SHANGHAI MEDICAL EQUIPMENT LTD2019-08-19
YSIOSIEMENS HEALTHCARE GMBH2019-08-16
YSIOSIEMENS HEALTHCARE GMBH2019-08-12
2019-08-12
2019-08-12
DURADIAGNOSTPHILIPS HEALTHCARE (SUZHOU) CO., LTD2019-08-09
PROTEUS XR/A RADIOGRAPHIC SYSTEMGE HANGWEI MEDICAL SYSTEMS CO., LTD.2019-07-29
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEMGE MEDICAL SYSTEMS, LLC2019-07-29
2019-07-05
2019-07-02
RADSPEED GENERAL X-RAY SYSTEMSHIMADZU MEDICAL SYSTEMS2019-06-24
GC85ASAMSUNG ELECTRONICS CO., LTD.2019-05-29
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