Sentinella 102, Sentinella 102 Horus
K-Number: K162052 · 2016-08-18
Decision Date2016-08-18
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Sentinella 102, Sentinella 102 Horus is a medical device manufactured by General Equipment For Medical Imaging (Oncovision-. It received FDA 510(k) clearance on 2016-08-18 under approval number K162052. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sentinella 102, Sentinella 102 Horus?
Sentinella 102, Sentinella 102 Horus is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by General Equipment For Medical Imaging (Oncovision-. The 510(k) number is K162052.
When was Sentinella 102, Sentinella 102 Horus approved by the FDA?
Sentinella 102, Sentinella 102 Horus received FDA 510(k) clearance on 2016-08-18, under approval number K162052.
What company makes Sentinella 102, Sentinella 102 Horus?
Sentinella 102, Sentinella 102 Horus is manufactured by General Equipment For Medical Imaging (Oncovision-.
What is the FDA product code for Sentinella 102, Sentinella 102 Horus?
The FDA product code for Sentinella 102, Sentinella 102 Horus is IYX.
Related Devices (Code: IYX)
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.