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FDA 510(k)

DIGITAL SPOT MAMMOGRAPHY SYSTEM

K-Number: K100692 · 2010-04-06

ApplicantHologic, Inc.
Decision Date2010-04-06
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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 2010-04-06 under 510(k) number K100692. 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 DIGITAL SPOT MAMMOGRAPHY SYSTEM?

DIGITAL SPOT MAMMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-06. The listed applicant is Hologic, Inc.. The 510(k) number is K100692.

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

DIGITAL SPOT MAMMOGRAPHY SYSTEM received FDA 510(k) clearance on 2010-04-06, under 510(k) number K100692.

Who is the listed applicant for 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 DIGITAL SPOT MAMMOGRAPHY SYSTEM?

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

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Other records listing Hologic, Inc. as applicant

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Related Devices (Code: IZH)

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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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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