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FDA 510(k)

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)

K-Number: K000976 · 2000-06-01

ApplicantInstrumentarium Imaging, Inc.
Decision Date2000-06-01
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Imaging, Inc.. It received FDA 510(k) clearance on 2000-06-01 under 510(k) number K000976. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)?

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) is a medical device that received FDA 510(k) clearance on 2000-06-01. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K000976.

When did DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) receive FDA 510(k) clearance?

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) received FDA 510(k) clearance on 2000-06-01, under 510(k) number K000976.

Who is the listed applicant for DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)?

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

What is the FDA product code for DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)?

The FDA product code for DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) is IZH.

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Other records listing Instrumentarium Imaging, Inc. as applicant

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Related Devices (Code: IZH)

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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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