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FDA 510(k)

QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000

K-Number: K952060 · 1995-06-05

ApplicantImage Analysis, Inc.
Decision Date1995-06-05
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 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 1995-06-05 under 510(k) number K952060. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000?

QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 is a medical device that received FDA 510(k) clearance on 1995-06-05. The listed applicant is Image Analysis, Inc.. The 510(k) number is K952060.

When did QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 receive FDA 510(k) clearance?

QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 received FDA 510(k) clearance on 1995-06-05, under 510(k) number K952060.

Who is the listed applicant for QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000?

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-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000?

The FDA product code for QCT-BONE MINERAL ANALYSIS SOFTWARE OR OCT-BMD OPTION OR OCT-5000 is KGI.

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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 SOFTWAREK941127QCT-BONE MINERAL ANALYSIS SOFTWAREK941126QCT-BONE MINERAL ANALYSIS PHANTOMK891931QCT-LUNG NODULE (TM) ANALYSIS PACKAGE

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Related Devices (Code: KGI)

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.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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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