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Breast Companion Software System

by Almen Laboratories, Inc.

PMA P100007

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 10 Feb 2012

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP100007 Date10 Feb 2012Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
Analyzer, medical image
PMA Number
FDA Product Code
MYN
Device Class
Class II
Regulation
21 CFR Part 892.2070
Advisory Committee
Radiology
FDA Decision
APWD Approval withdrawn

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