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FDA 510(k)

SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM

K-Number: K123509 · 2013-03-29

ApplicantHitachi Medical Systems America, Inc.
Decision Date2013-03-29
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2013-03-29 under 510(k) number K123509. 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 SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM?

SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-29. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K123509.

When did SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM receive FDA 510(k) clearance?

SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM received FDA 510(k) clearance on 2013-03-29, under 510(k) number K123509.

Who is the listed applicant for SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM?

The FDA product code for SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM is JAK.

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Other records listing Hitachi Medical Systems America, Inc. as applicant

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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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.

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