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FDA 510(k)

PRIMELUNG

K-Number: K024149 · 2003-02-21

ApplicantAccuimage Diagnostics Corp.
Decision Date2003-02-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRIMELUNG is the device name listed in this FDA 510(k) record. The listed applicant is Accuimage Diagnostics Corp.. It received FDA 510(k) clearance on 2003-02-21 under 510(k) number K024149. 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 PRIMELUNG?

PRIMELUNG is a medical device that received FDA 510(k) clearance on 2003-02-21. The listed applicant is Accuimage Diagnostics Corp.. The 510(k) number is K024149.

When did PRIMELUNG receive FDA 510(k) clearance?

PRIMELUNG received FDA 510(k) clearance on 2003-02-21, under 510(k) number K024149.

Who is the listed applicant for PRIMELUNG?

The FDA 510(k) record lists Accuimage Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMELUNG?

The FDA product code for PRIMELUNG is JAK.

Related Clinical Trials

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Other records listing Accuimage Diagnostics Corp. 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.

K012106ACCUIMAGE SMARTGATE UPGRADEK990241ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP

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

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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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