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Luma Cervical Imaging System

by Spectra Science

PMA P040028

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 16 Mar 2006

PMA

FDA recalls

None ongoing

1 closed

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United StatesFDA PMAAPWD Approval withdrawn NumberP040028 Date16 Mar 2006Approval withdrawnStatusWithdrawn

Recalls

1 recall · FDA

    • Terminated Z-0988-2007 FDA Unclassified (pre-2012) initiated 15 May 2007

    Power supply may fail and render the unit inoperable.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
Sensor, electro-optical (for cervical cancer)
PMA Number
FDA Product Code
MWM
Device Class
Class III
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APWD Approval withdrawn

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