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FDA 510(k)

TISSUE-EQUIVALENT BREAST SIMULATOR

K-Number: K865100 · 1987-01-12

ApplicantComputerized Imaging Reference Systems, Inc.
Decision Date1987-01-12
Product CodeIXF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TISSUE-EQUIVALENT BREAST SIMULATOR 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 1987-01-12 under 510(k) number K865100. The device is classified under product code IXF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TISSUE-EQUIVALENT BREAST SIMULATOR?

TISSUE-EQUIVALENT BREAST SIMULATOR is a medical device that received FDA 510(k) clearance on 1987-01-12. The listed applicant is Computerized Imaging Reference Systems, Inc.. The 510(k) number is K865100.

When did TISSUE-EQUIVALENT BREAST SIMULATOR receive FDA 510(k) clearance?

TISSUE-EQUIVALENT BREAST SIMULATOR received FDA 510(k) clearance on 1987-01-12, under 510(k) number K865100.

Who is the listed applicant for TISSUE-EQUIVALENT BREAST SIMULATOR?

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 TISSUE-EQUIVALENT BREAST SIMULATOR?

The FDA product code for TISSUE-EQUIVALENT BREAST SIMULATOR is IXF.

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 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.

K852528BONE DENSITY CT PHANTOM

Related Devices (Code: IXF)

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.

K851812DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711Victoreen, Inc.K834482TISSUE MIMICKING ULTRASOUND PHANTOMSRadiation Measurements, Inc.K834481DOPPLER PHANTOM FLOW CONTROL SYSRadiation Measurements, Inc.K8102541.5` FOCAL SPOT RESOLUTION PATTERNMachlett Laboratories, 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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