Skip to the page
Get started free

Data / Medical devices / India / Skanray Technologies Limited

Skanray Technologies Limited: FDA-registered device maker in Mysore Karnataka, India, 12 510(k) clearances

Skanray Technologies Limited is registered with the FDA (registration 3009001657) in Mysore Karnataka, India. It lists 25 device types. The FDA files 12 510(k) clearances under its listings, the newest dated October 27, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Skanray Technologies Limited
FDA registration number
3009001657
Address
Plot# 15-17, Hebbal Industrial Area Hebbal, Mysore Karnataka, India, 570016
Owner or operator
Skanray Technologies Limited (10036010)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer
First device listed
April 13, 2011
Registered through
2026
Brand names listed
Capnostream, Capnostream 20P, Capnostream 20P with HiFi CO2 monitoring, IMAGESCAN HD, INTRA SKAN DC, INTRASKAN DC, INTRASKAN DC PLUS, PodSKAN HF Diagnostic X-ray System and more

Devices it lists

DeviceProduct codeClassRoleSource
Alarm, Blood-PressureDSJ2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Complaint file establishment, Manufactureraccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Complaint file establishment, Manufactureraccessdata.fda.gov
Computer, Diagnostic, Pre-Programmed, Single-FunctionDXG2Complaint file establishment, Manufactureraccessdata.fda.gov
Continuous Measurement ThermometerFLL2Complaint file establishment, Manufactureraccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Complaint file establishment, Manufactureraccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Complaint file establishment, Manufactureraccessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)DRT2Complaint file establishment, Manufactureraccessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)MWI2Complaint file establishment, Manufactureraccessdata.fda.gov
OximeterDQA2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov
Probe, ThermodilutionKRB2Complaint file establishment, Manufactureraccessdata.fda.gov
Recorder, Paper ChartDSF1Complaint file establishment, Manufactureraccessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)MQB2Complaint file establishment, Manufactureraccessdata.fda.gov
System, Measurement, Blood-Pressure, Non-InvasiveDXN2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, MobileIZL2Complaint file establishment, Manufactureraccessdata.fda.gov
System, X-Ray, StationaryKPR2Complaint file establishment, Manufactureraccessdata.fda.gov
Transducer, Blood-Pressure, ExtravascularDRS2Complaint file establishment, Manufactureraccessdata.fda.gov
Unit, X-Ray, Extraoral With TimerEHD2Contract manufacturer, Manufactureraccessdata.fda.gov
Ventilatory Effort RecorderMNR2Complaint file establishment, Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 27, 2023K231761PodSKAN HF Diagnostic X-ray SystemKPRSubstantially EquivalentSkanray Technologies Limitedaccessdata.fda.gov
April 1, 2022K220518SKANRAD 400KPRSubstantially EquivalentSkanray Technologies Limitedaccessdata.fda.gov
March 4, 2022K212940Skanmobile, Skanmobile-DrIZLSubstantially EquivalentSkanray Technologies Limitedaccessdata.fda.gov
May 25, 2018K172147STAR 65MWISubstantially EquivalentSkanray Technologies Pvt, Ltd.accessdata.fda.gov
November 24, 2017K170946Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V VariantOXOSubstantially EquivalentSkanray Technologies Private Limitedaccessdata.fda.gov
June 8, 2017K170967Intraskan DC PlusEHDSubstantially EquivalentSkanray Technologies Private Limitedaccessdata.fda.gov
February 23, 2016K152831Spot SkanDXNSubstantially EquivalentSkanray Technologies Private Limitedaccessdata.fda.gov
February 14, 2016K151512Star 60MWISubstantially EquivalentSkanray Technologies Private Limitedaccessdata.fda.gov
June 17, 2015K150512STAR 90MWISubstantially EquivalentSkanray Technologies Pvt, Ltd.accessdata.fda.gov
May 27, 2011K111330AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAYEHDSubstantially EquivalentSkanray Technologiesaccessdata.fda.gov
March 18, 2011K103579INTRA SKAN DCEHDSubstantially EquivalentSkanray Technologiesaccessdata.fda.gov
November 20, 2009K092153SKYLINE 55, MODEL VER 1MWISubstantially EquivalentLarsen & Toubro Limitedaccessdata.fda.gov

Compare with other makers

Updated October 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.