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FDA 510(k)

OSDX HIP BMD SYSTEM

K-Number: K082402 · 2008-10-16

ApplicantImaging Therapeutics, Inc.
Decision Date2008-10-16
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OSDX HIP BMD SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imaging Therapeutics, Inc.. It received FDA 510(k) clearance on 2008-10-16 under 510(k) number K082402. 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 OSDX HIP BMD SYSTEM?

OSDX HIP BMD SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-16. The listed applicant is Imaging Therapeutics, Inc.. The 510(k) number is K082402.

When did OSDX HIP BMD SYSTEM receive FDA 510(k) clearance?

OSDX HIP BMD SYSTEM received FDA 510(k) clearance on 2008-10-16, under 510(k) number K082402.

Who is the listed applicant for OSDX HIP BMD SYSTEM?

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

What is the FDA product code for OSDX HIP BMD SYSTEM?

The FDA product code for OSDX HIP BMD SYSTEM is KGI.

Related Clinical Trials

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.

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Other records listing Imaging Therapeutics, 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.

K033242KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)

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

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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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