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Onepass Nuclear Imaging System, Model 70-500101

by Gvi Technology Partners

510(k) K023373

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023373 Date3 Jan 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0527-04 FDA Unclassified (pre-2012) initiated 16 Jan 2004

    Due to limitations in the operating software, the acquired scan may not be processed properly.

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  • Withdrawn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
IYX
Device Class
Class I
Regulation
21 CFR Part 892.1100
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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