iNtuition-T1 Mapping and T2/T2* Mapping
K-Number: K180916 · 2018-09-24
ApplicantTerarecon,Inc.
Decision Date2018-09-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
iNtuition-T1 Mapping and T2/T2* Mapping is a medical device manufactured by Terarecon,Inc.. It received FDA 510(k) clearance on 2018-09-24 under approval number K180916. 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 iNtuition-T1 Mapping and T2/T2* Mapping?
iNtuition-T1 Mapping and T2/T2* Mapping is a medical device that received FDA 510(k) clearance on 2018-09-24. It is manufactured by Terarecon,Inc.. The 510(k) number is K180916.
When was iNtuition-T1 Mapping and T2/T2* Mapping approved by the FDA?
iNtuition-T1 Mapping and T2/T2* Mapping received FDA 510(k) clearance on 2018-09-24, under approval number K180916.
What company makes iNtuition-T1 Mapping and T2/T2* Mapping?
iNtuition-T1 Mapping and T2/T2* Mapping is manufactured by Terarecon,Inc..
What is the FDA product code for iNtuition-T1 Mapping and T2/T2* Mapping?
The FDA product code for iNtuition-T1 Mapping and T2/T2* Mapping is LLZ.
Other Devices by Terarecon,Inc.
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.