Ambra PACS
K-Number: K231360 · 2023-06-07
ApplicantDicom Grid Dba Ambra Health
Decision Date2023-06-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ambra PACS is a medical device manufactured by Dicom Grid Dba Ambra Health. It received FDA 510(k) clearance on 2023-06-07 under approval number K231360. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ambra PACS?
Ambra PACS is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Dicom Grid Dba Ambra Health. The 510(k) number is K231360.
When was Ambra PACS approved by the FDA?
Ambra PACS received FDA 510(k) clearance on 2023-06-07, under approval number K231360.
What company makes Ambra PACS?
Ambra PACS is manufactured by Dicom Grid Dba Ambra Health.
What is the FDA product code for Ambra PACS?
The FDA product code for Ambra PACS is LLZ.
Related Devices (Code: LLZ)
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.