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FDA 510(k)

OmniTom Elite

K-Number: K223447 · 2023-06-01

ApplicantNeurologica Corporation, A Subsidiary of Samsung
Decision Date2023-06-01
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OmniTom Elite is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation, A Subsidiary of Samsung. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K223447. 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 2023-06-01. The listed applicant is Neurologica Corporation, A Subsidiary of Samsung. The 510(k) number is K223447.

When did OmniTom Elite receive FDA 510(k) clearance?

OmniTom Elite received FDA 510(k) clearance on 2023-06-01, under 510(k) number K223447.

Who is the listed applicant for OmniTom Elite?

The FDA 510(k) record lists Neurologica Corporation, A Subsidiary of Samsung as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OmniTom Elite?

The FDA product code for OmniTom Elite is JAK.

Other records listing Neurologica Corporation, A Subsidiary of Samsung as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242811BodyTom 64

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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