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FDA 510(k)

QCT-LUNG NODULE (TM) ANALYSIS PACKAGE

K-Number: K891931 · 1989-05-18

ApplicantImage Analysis, Inc.
Decision Date1989-05-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QCT-LUNG NODULE (TM) ANALYSIS PACKAGE is the device name listed in this FDA 510(k) record. The listed applicant is Image Analysis, Inc.. It received FDA 510(k) clearance on 1989-05-18 under 510(k) number K891931. 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 QCT-LUNG NODULE (TM) ANALYSIS PACKAGE?

QCT-LUNG NODULE (TM) ANALYSIS PACKAGE is a medical device that received FDA 510(k) clearance on 1989-05-18. The listed applicant is Image Analysis, Inc.. The 510(k) number is K891931.

When did QCT-LUNG NODULE (TM) ANALYSIS PACKAGE receive FDA 510(k) clearance?

QCT-LUNG NODULE (TM) ANALYSIS PACKAGE received FDA 510(k) clearance on 1989-05-18, under 510(k) number K891931.

Who is the listed applicant for QCT-LUNG NODULE (TM) ANALYSIS PACKAGE?

The FDA 510(k) record lists Image Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QCT-LUNG NODULE (TM) ANALYSIS PACKAGE?

The FDA product code for QCT-LUNG NODULE (TM) ANALYSIS PACKAGE is JAK.

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Other records listing Image Analysis, Inc. 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.

K040782N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XXK031991DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUSK992246QCT BONE MINERAL ANALYSIS SOFTWAREK952060QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000K941127QCT-BONE MINERAL ANALYSIS SOFTWAREK941126QCT-BONE MINERAL ANALYSIS PHANTOM

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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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