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Eos

by Biospace Med

510(k) K071546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK071546 Date18 Sep 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2692-2011 FDA Unclassified (pre-2012) initiated 13 Apr 2011 on shared 510(k) K071546

    Print true size, print requests from the EOS acquisition station or the sterEOS image review station may, in certain cases, be affected by a different enlargement factor during printing. T

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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