FDA 510(k)

S-scan

K-Number: K161238 · 2016-07-08

Decision Date2016-07-08

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

S-scan is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-07-08 under approval number K161238. 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 S-scan?

S-scan is a medical device that received FDA 510(k) clearance on 2016-07-08. It is manufactured by Esaote, S.p.A.. The 510(k) number is K161238.

When was S-scan approved by the FDA?

S-scan received FDA 510(k) clearance on 2016-07-08, under approval number K161238.

What company makes S-scan?

S-scan is manufactured by Esaote, S.p.A..

What is the FDA product code for S-scan?

The FDA product code for S-scan is LNH.

Other Devices by Esaote, S.p.A.

K161973G-scan Brio, S-scan K162290MyLabSix CrystaLine K1613596400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System K1532776200 Ultrasound System and 6250 Ultrasound System K153039MRI Dynamic Analysis Plus K1630826200 Ultrasound System and 6250 Ultrasound System

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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.