IDx-DR
K-Number: K203629 · 2021-06-10
ApplicantDigital Diagnostics, Inc.
Decision Date2021-06-10
Product CodePIB
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
IDx-DR is a medical device manufactured by Digital Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-06-10 under approval number K203629. The device is classified under product code PIB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IDx-DR?
IDx-DR is a medical device that received FDA 510(k) clearance on 2021-06-10. It is manufactured by Digital Diagnostics, Inc.. The 510(k) number is K203629.
When was IDx-DR approved by the FDA?
IDx-DR received FDA 510(k) clearance on 2021-06-10, under approval number K203629.
What company makes IDx-DR?
IDx-DR is manufactured by Digital Diagnostics, Inc..
What is the FDA product code for IDx-DR?
The FDA product code for IDx-DR is PIB.
Other Devices by Digital Diagnostics, Inc.
Related Devices (Code: PIB)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.