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Transcan T-Scan 2000

by Mirabel Medical Systems, Inc.

PMA P970033

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P970033↗

FDA record

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 PMAAPPR Approved NumberP970033 Date16 Apr 1999ApprovedStatusActive

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  • Withdrawn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 Active

Specification

PMA

Trade Name
T-Scan 2000
Generic Name
Imager, breast, electrical impedance
PMA Number
FDA Product Code
NCL
Device Class
Class III
Advisory Committee
Radiology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Transcan T-Scan 2000 is an Imager, Breast, Electrical Impedance, designed to provide supplementary diagnostic information during mammography. It evaluates breast tissue using electrical impedance to assist radiologists in assessing equivocal findings classified under ACR BI-RADS categories 3 or 4, aiding decision-making for biopsy recommendations.

This device is supplied as a Class III medical instrument and is intended for use in radiology settings. It is not single-use or reusable, as its specifications do not indicate sterility requirements or disposal protocols. The T-Scan 2000 holds an FDA PMA approval (P970033) and is regulated under the NCL product code, with no explicit MRI safety or size variations noted in the data.