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Ablatherm Integrated Imaging

by Edap Technomed, Inc.

510(k) K153023

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 NumberK153023 Date6 Nov 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0049-2018 FDA Class II initiated 14 Aug 2017

    The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining devices in the U.S. until supporting clinical data can be submitted and evaluated by FDA.

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  • Withdrawn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
PLP
Device Class
Class II
Regulation
21 CFR Part 876.4340
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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