First Source, Inc.

Medical device manufacturer in Rochester, NY.

3510(k) clearances
0PMA approvals
2recalls

Device types

510(k) clearances

510(k)DeviceDecision
K240009iQFlex ProIZL · Traditional 07/03/2024SE
K221081iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray SystemIZL · Traditional 06/13/2022SE
K203703I-Q ViewMQB · Traditional 03/24/2021SE

Recalls

RecallProductInitiated
Z-2247-2024 Class IIFirst Source iQ Flex M. Portable cart and platform that supports an X-ray system and…Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. 05/09/2024Open, Classified
Z-2246-2024 Class IIFirst Source Vision M. Portable cart and platform that supports an X-ray system and…Potential for the bolt that secures the positioning arm to the gas spring to come loose and fall onto patient. 05/09/2024Open, Classified