Somatom Confidence ® RT Pro
K-Number: K162302 · 2016-12-16
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-12-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Somatom Confidence ® RT Pro is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K162302. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Somatom Confidence ® RT Pro?
Somatom Confidence ® RT Pro is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K162302.
When was Somatom Confidence ® RT Pro approved by the FDA?
Somatom Confidence ® RT Pro received FDA 510(k) clearance on 2016-12-16, under approval number K162302.
What company makes Somatom Confidence ® RT Pro?
Somatom Confidence ® RT Pro is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Somatom Confidence ® RT Pro?
The FDA product code for Somatom Confidence ® RT Pro is JAK.
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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.