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Aspire Cr for Mammography System (Crm); Fcr Aspire Crn (Reader). Note for General Radiography, Reader Is Carbon XL2/Fcr

by Fujifilm Medical System U.S.A., Inc.

510(k) K111646

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111646 Date8 Dec 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MUE
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 892.1715
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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