PodSKAN HF Diagnostic X-ray System
Skanray Technologies Limited
SKANRAY TECHNOLOGIES LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009001657 | 3009001657 | SKANRAY TECHNOLOGIES LIMITED | 1 | N | 2026-01-01 | Plot# 15-17, Hebbal Industrial Area Hebbal Mysore Karnataka IN 570016 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 127959 | 1915342260 | K231761 | PodSKAN HF Diagnostic X-ray System | KPR | 2023-10-27 |
| 127959 | 1260745880 | K220518 | SKANRAD 400 | KPR | 2022-04-01 |
| 127959 | 1806897258 | K212940 | Skanmobile, Skanmobile-Dr | IZL | 2022-03-04 |
| 127959 | 1987849483 | K172147 | STAR 65 | MWI | 2018-05-25 |
| 127959 | 1128001030 | K170967 | Intraskan DC Plus | EHD | 2017-06-08 |
| 127959 | 1367693665 | K170946 | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant | OXO | 2017-11-24 |
| 127959 | 1545514343 | K152831 | Spot Skan | DXN | 2016-02-23 |
| 127959 | 1853959172 | K151512 | Star 60 | MWI | 2016-02-14 |
| 127959 | 1724949611 | K150512 | STAR 90 | MWI | 2015-06-17 |
| 127959 | 1424063036 | K111330 | AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY | EHD | 2011-05-27 |
| 127959 | 1806173813 | K103579 | INTRA SKAN DC | EHD | 2011-03-18 |
| 127959 | 1774073392 | K092153 | SKYLINE 55, MODEL VER 1 | MWI | 2009-11-20 |
| 127959 | 1101632226 | ||||
| 127959 | 1777288191 | ||||
| 127959 | 1955593509 |
Product Codes Associated With Registrations#
PMN#
SKANRAD 400
Skanray Technologies Limited
Skanmobile, Skanmobile-Dr
Skanray Technologies Limited
GUDID#
PodSKAN HF Diagnostic X-ray System - PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A Wall socket with 120 VAC or 240 VAC, 50/60 Hz.. The technology incorporates feedback circuits to ensure highest accuracy & reproducibility of X-Ray output.
2023-12-22
Star 60 - Multipara Patient monitoring system
2019-05-24
Star 90 - Multipara Patient monitoring system
2019-09-27
Skyline 55 wireless - Central Nursing Station or Central Monitoring System
2019-06-05
Skyline 55 wireless - Central Nursing Station or Central Monitoring System
2019-06-05
Star 60 - Multipara Patient monitoring system
2019-05-24
Star 90 - Multi-Parameter Patient Monitoring System
2019-05-22
STAR 65 - Multi-Parameter Patient Monitoring System
2019-01-21
Spotskan - Multi-Parameter Spot Check Device
2019-05-24
SPOTSKAN - Multi-Parameter Spot Check Device
2019-05-24
SKANRAD 400 - Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation
2022-05-11
SKANMOBILE - Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors,one for control / supervisory functions and another for man-machine/user interface. The technology incorporatesfeedback circuits to ensure accuracy & reproducibility of X-Ray output.
2022-04-21
SKANMOBILE DR - SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detectorand operator console for digital imaging integrated with high frequency generator.
2022-04-21
Skan C Mobile C - Arm X - Ray system - SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications.
2019-01-21
Intraskan DC Plus - "Intraskan DC Plus with 33"" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose."
2020-08-10
Intraskan DC Plus - Intraskan DC Plus Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose.
2020-08-10
Rayos DC - "Rayos DC with 15"" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
2020-08-10
Rayos DC - "Rayos DC with 24"" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
2020-08-10
Rayos DC - "Rayos DC with 33"" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
2020-08-10
Rayos DC - Rayos DC Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose
2020-08-10
Imagescan HD - "Imagescan HD with 15"" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
2020-08-10
Imagescan HD - "Imagescan HD with 24"" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
2020-08-10
Imagescan HD - "Imagescan HD with 33"" Straight arm is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose"
2020-08-10
Imagescan HD - Imagescan HD Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose
2020-08-10
Intraskan DC Plus - "Intraskan DC Plus with 24"" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose."
2019-09-27
Intraskan DC Plus - "Intraskan DC Plus with 15"" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in DentalRadiography for diagnostic purpose."
2019-09-26