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Wellhofer WP700 V. 3.2

by Medical Physics Instrumentation, Inc.

510(k) K945321

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK945321 Date12 Jul 1995ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2220-2017 FDA Class II initiated 26 Apr 2017

    When the Stealth Chamber is used as a reference detector in relative dosimetry, deviation in the measured PDDs at shallow depths and geometric shadowing of measured profiles may appear.

    • Terminated Z-0683-2016 FDA Class II initiated 10 Dec 2015

    When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner.

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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent