SpotLight CT
K-Number: K161066 · 2016-08-10
ApplicantArineta , Ltd.
Decision Date2016-08-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SpotLight CT is a medical device manufactured by Arineta , Ltd.. It received FDA 510(k) clearance on 2016-08-10 under approval number K161066. 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 SpotLight CT?
SpotLight CT is a medical device that received FDA 510(k) clearance on 2016-08-10. It is manufactured by Arineta , Ltd.. The 510(k) number is K161066.
When was SpotLight CT approved by the FDA?
SpotLight CT received FDA 510(k) clearance on 2016-08-10, under approval number K161066.
What company makes SpotLight CT?
SpotLight CT is manufactured by Arineta , Ltd..
What is the FDA product code for SpotLight CT?
The FDA product code for SpotLight CT is JAK.
Other Devices by Arineta , Ltd.
Related Devices (Code: JAK)
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.
K163213Revolution CTGe Medical Systems, LLC
K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.
K160723OnSight 3D Extremity SystemCarestream Health, Inc.
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.
K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.
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.