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FDA 510(k)

BONE DENSITY CT PHANTOM

K-Number: K852528 · 1985-09-26

ApplicantComputerized Imaging Reference Systems, Inc.
Decision Date1985-09-26
Product CodeIXG
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BONE DENSITY CT PHANTOM is the device name listed in this FDA 510(k) record. The listed applicant is Computerized Imaging Reference Systems, Inc.. It received FDA 510(k) clearance on 1985-09-26 under 510(k) number K852528. The device is classified under product code IXG. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE DENSITY CT PHANTOM?

BONE DENSITY CT PHANTOM is a medical device that received FDA 510(k) clearance on 1985-09-26. The listed applicant is Computerized Imaging Reference Systems, Inc.. The 510(k) number is K852528.

When did BONE DENSITY CT PHANTOM receive FDA 510(k) clearance?

BONE DENSITY CT PHANTOM received FDA 510(k) clearance on 1985-09-26, under 510(k) number K852528.

Who is the listed applicant for BONE DENSITY CT PHANTOM?

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

What is the FDA product code for BONE DENSITY CT PHANTOM?

The FDA product code for BONE DENSITY CT PHANTOM is IXG.

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Other records listing Computerized Imaging Reference Systems, 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.

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Related Devices (Code: IXG)

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.

K913243BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLEBennett X-Ray Corp.K840131COMPUTED TOMOGRAPHY CALIBRATION PHANTImatron, Inc.K834465SERIES OF DIAGNOSTIC PHANTOMSCirs, Inc.

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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