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FDA 510(k)

WORKSTATIONONE BREAST IMAGING WORKSTATION

K-Number: K073272 · 2007-12-11

ApplicantThree Palm Software, LLC
Decision Date2007-12-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WORKSTATIONONE BREAST IMAGING WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Three Palm Software, LLC. It received FDA 510(k) clearance on 2007-12-11 under 510(k) number K073272. 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 WORKSTATIONONE BREAST IMAGING WORKSTATION?

WORKSTATIONONE BREAST IMAGING WORKSTATION is a medical device that received FDA 510(k) clearance on 2007-12-11. The listed applicant is Three Palm Software, LLC. The 510(k) number is K073272.

When did WORKSTATIONONE BREAST IMAGING WORKSTATION receive FDA 510(k) clearance?

WORKSTATIONONE BREAST IMAGING WORKSTATION received FDA 510(k) clearance on 2007-12-11, under 510(k) number K073272.

Who is the listed applicant for WORKSTATIONONE BREAST IMAGING WORKSTATION?

The FDA 510(k) record lists Three Palm Software, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WORKSTATIONONE BREAST IMAGING WORKSTATION?

The FDA product code for WORKSTATIONONE BREAST IMAGING WORKSTATION is LLZ.

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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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