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FDA 510(k)

BodyTom 64

K-Number: K242811 · 2025-03-14

ApplicantNeurologica Corporation, A Subsidiary of Samsung
Decision Date2025-03-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BodyTom 64 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 2025-03-14 under 510(k) number K242811. 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 BodyTom 64?

BodyTom 64 is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Neurologica Corporation, A Subsidiary of Samsung. The 510(k) number is K242811.

When did BodyTom 64 receive FDA 510(k) clearance?

BodyTom 64 received FDA 510(k) clearance on 2025-03-14, under 510(k) number K242811.

Who is the listed applicant for BodyTom 64?

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 BodyTom 64?

The FDA product code for BodyTom 64 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.

K223447OmniTom Elite

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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