OmniTom Elite
K-Number: K211711 · 2022-02-25
Decision Date2022-02-25
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OmniTom Elite is a medical device manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. It received FDA 510(k) clearance on 2022-02-25 under approval number K211711. 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 OmniTom Elite?
OmniTom Elite is a medical device that received FDA 510(k) clearance on 2022-02-25. It is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics. The 510(k) number is K211711.
When was OmniTom Elite approved by the FDA?
OmniTom Elite received FDA 510(k) clearance on 2022-02-25, under approval number K211711.
What company makes OmniTom Elite?
OmniTom Elite is manufactured by Neurologica Corporation, A Subsidiary of Samsung Electronics.
What is the FDA product code for OmniTom Elite?
The FDA product code for OmniTom Elite is JAK.
Other Devices by Neurologica Corporation, A Subsidiary of Samsung Electronics
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.