FDA.reportPublic FDA data

510(k) K132289

Device
GEMSS MEDICAL SYSTEMS SURGICAL MOBILE FLUOROSCOPIC X-RAY SYSTEM
Applicant
GEMSS MEDICAL SYSTEMS CO. LTD
510(k) number
K132289
Product code
JAA  
Decision
Substantially Equivalent (SESE)
Decision date
2014-06-16
Date received
2013-07-23
Regulation
892.1650
Classification name
System, X-ray, Fluoroscopic, Image-intensified
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HARVEY KNAUSS
Address
11874 S. Evelyn Cir. Houston TX US 77071 77071

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JAA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation2026-05-29
K251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLC2025-09-16
K242488Soteria E-ViewOmega Medical Imaging, LLC2025-01-06
K242948Adora DRFi (04550010)Nrt X-Ray A/S2024-12-23
K233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech America2024-06-26
K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH2024-01-11
K232910CombiDiagnost R90Philips Medical Systems Dmc GmbH2023-10-19
K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation2023-09-12
K220871NautilusDornier Medtech America, Inc.2022-04-18
K212890Nyquist.IQOmega Medical Imaging, LLC2021-12-13
K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH2021-09-21
K212145DR 800 with DSA, DR 800Agfa N.V.2021-08-31
K210469Insight Agile DRFImaging Engineering, LLC2021-07-27
K203428Ziehm Vision RFDZiehm Imaging GmbH2021-03-17
K203010Platinum dRF Imaging SystemApelem-Dms Group2021-01-22

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases