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Sienet Archive Server, Isa I, Isa II Storage Serve

by Siemens Gammasonics, Inc.

510(k) K920310

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 NumberK920310 Date30 Mar 1992ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0890-2007 FDA Unclassified (pre-2012) initiated 2 May 2007

    System could crash and result in data loss.

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  • Withdrawn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
LMD
Device Class
Class I
Regulation
21 CFR Part 892.2020
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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