Hepatica v1 (Hepatica v1.0.0)
K-Number: K203280 · 2021-01-12
ApplicantPerspectum, Ltd.
Decision Date2021-01-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Hepatica v1 (Hepatica v1.0.0) is a medical device manufactured by Perspectum, Ltd.. It received FDA 510(k) clearance on 2021-01-12 under approval number K203280. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hepatica v1 (Hepatica v1.0.0)?
Hepatica v1 (Hepatica v1.0.0) is a medical device that received FDA 510(k) clearance on 2021-01-12. It is manufactured by Perspectum, Ltd.. The 510(k) number is K203280.
When was Hepatica v1 (Hepatica v1.0.0) approved by the FDA?
Hepatica v1 (Hepatica v1.0.0) received FDA 510(k) clearance on 2021-01-12, under approval number K203280.
What company makes Hepatica v1 (Hepatica v1.0.0)?
Hepatica v1 (Hepatica v1.0.0) is manufactured by Perspectum, Ltd..
What is the FDA product code for Hepatica v1 (Hepatica v1.0.0)?
The FDA product code for Hepatica v1 (Hepatica v1.0.0) is LNH.
Other Devices by Perspectum, Ltd.
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
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.