Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

XPress BCD Breast Compression Device

K-Number: K163388 · 2017-07-19

ApplicantXpress Bcd, LLC
Decision Date2017-07-19
Product CodePOY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPress BCD Breast Compression Device is the device name listed in this FDA 510(k) record. The listed applicant is Xpress Bcd, LLC. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K163388. The device is classified under product code POY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPress BCD Breast Compression Device?

XPress BCD Breast Compression Device is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Xpress Bcd, LLC. The 510(k) number is K163388.

When did XPress BCD Breast Compression Device receive FDA 510(k) clearance?

XPress BCD Breast Compression Device received FDA 510(k) clearance on 2017-07-19, under 510(k) number K163388.

Who is the listed applicant for XPress BCD Breast Compression Device?

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

What is the FDA product code for XPress BCD Breast Compression Device?

The FDA product code for XPress BCD Breast Compression Device is POY.

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.

↑