iQFlex Pro
First Source, Inc.
FIRST SOURCE INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004063527 | 3004063527 | FIRST SOURCE INC. | 1 | Y | 2026-01-01 | 3495 Winton Pl Bldg E Ste 1 Rochester NY US 14623 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 61921 | 1642859091 | K240009 | iQFlex Pro | IZL | 2024-07-03 |
| 61921 | 1383995933 | K221081 | iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System | IZL | 2022-06-13 |
| 61921 | 1990190295 | K203703 | I-Q View | MQB | 2021-03-24 |
| 61921 | 1410177552 | K183388 | JADE Mobile X-Ray | IZL | 2019-02-05 |
| 61921 | 1629372971 | K151038 | EPX-Series Mobile X-ray System | IZL | 2015-07-24 |
| 61921 | 2017711119 | K150725 | Visaris Avanse | KPR | 2015-06-08 |
| 61921 | 1127983946 | K032628 | PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF | IZL | 2004-02-02 |
| 61921 | 1232912485 |
Product Codes Associated With Registrations#
PMN#
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
First Source, Inc.
I-Q View
First Source, Inc.
GUDID#
iQ View - The I-Q View is a software package to be used with FDA cleared solid-state imaging receptors. It functions as a diagnostic x-ray image acquisition platform and allows these images to be transferred to hard copy, softcopy, and archive devices via DICOM protocol.
2023-06-13
iQ Flex - This Mobile X-ray System (Model: iQFlex M/iQFlex MD) consists of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. A cart or a stand can be used with the iQFlex MD. The iQFlex M/iQFlex MD is used with a film-cassette or flat-panel detector.
2023-06-13
iQ Panorama - A weight bearing stand that will allow a patient to be positioned for various x-ray examinations of spine and lower extremities.
2023-06-12
iQ Elevation - A weight bearing stand that will allow a patient to be positioned for various U-Arm x-ray examinations of lower extremities.
2023-06-12
iQ Flex - Mobile X-ray System consisting of a LED display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, and a collimator. The iQFlex M is used with a film-cassette or flat-panel detector.
2023-06-12