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FDA 510(k)

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

K-Number: K040884 · 2004-04-23

ApplicantHologic, Inc.
Decision Date2004-04-23
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2004-04-23 under 510(k) number K040884. 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 LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM?

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-23. The listed applicant is Hologic, Inc.. The 510(k) number is K040884.

When did LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM receive FDA 510(k) clearance?

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM received FDA 510(k) clearance on 2004-04-23, under 510(k) number K040884.

Who is the listed applicant for LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM?

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

What is the FDA product code for LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM?

The FDA product code for LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM is IZH.

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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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