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FDA 510(k)

R2 DIGITALNOW HD(DIGITALNOW HD)

K-Number: K091368 · 2009-06-04

ApplicantHologic, Inc.
Decision Date2009-06-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

R2 DIGITALNOW HD(DIGITALNOW HD) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2009-06-04 under 510(k) number K091368. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R2 DIGITALNOW HD(DIGITALNOW HD)?

R2 DIGITALNOW HD(DIGITALNOW HD) is a medical device that received FDA 510(k) clearance on 2009-06-04. The listed applicant is Hologic, Inc.. The 510(k) number is K091368.

When did R2 DIGITALNOW HD(DIGITALNOW HD) receive FDA 510(k) clearance?

R2 DIGITALNOW HD(DIGITALNOW HD) received FDA 510(k) clearance on 2009-06-04, under 510(k) number K091368.

Who is the listed applicant for R2 DIGITALNOW HD(DIGITALNOW HD)?

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 R2 DIGITALNOW HD(DIGITALNOW HD)?

The FDA product code for R2 DIGITALNOW HD(DIGITALNOW HD) is LLZ.

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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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