IDx-DR v2.3
K-Number: K213037 · 2022-06-17
ApplicantDigital Diagnostics, Inc.
Decision Date2022-06-17
Product CodePIB
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
IDx-DR v2.3 is a medical device manufactured by Digital Diagnostics, Inc.. It received FDA 510(k) clearance on 2022-06-17 under approval number K213037. 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 v2.3?
IDx-DR v2.3 is a medical device that received FDA 510(k) clearance on 2022-06-17. It is manufactured by Digital Diagnostics, Inc.. The 510(k) number is K213037.
When was IDx-DR v2.3 approved by the FDA?
IDx-DR v2.3 received FDA 510(k) clearance on 2022-06-17, under approval number K213037.
What company makes IDx-DR v2.3?
IDx-DR v2.3 is manufactured by Digital Diagnostics, Inc..
What is the FDA product code for IDx-DR v2.3?
The FDA product code for IDx-DR v2.3 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.