DISCOVERY IQ— 510(k) K141477

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K141477 for DISCOVERY IQ, Substantially Equivalent on 2014-09-18. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2014-06-04
Decision date: 2014-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPS

K261305 — MICSI-PET2026-09-11
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K261315 — Symbia Pro.specta Q3 (11364751) +3 more2026-05-21
K260524 — uMI Panvivo (5 models)2026-04-03
K253564 — uMI Panvivo (4 models)2026-02-13

More clearances from Ge Medical Systems, LLC

K253560 — Enhanced Boundary for PCCT2026-06-24
K253502 — Critical Care Suite with Enteric Tube Positioning AI Algorithm2026-04-14
K253520 — Photonova Spectra, Photonova Spectra Select2026-03-20
K253780 — SIGNA Bolt2026-02-06
K253779 — SIGNA Sprint Select2026-02-05

Recalls naming K141477

K-number listed on FDA's recall record

Z-1748-2019 — Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.Class II·Ongoing·GE Healthcare, LLC·20190212
Z-2578-2018 — Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22Class II·Terminated·GE Healthcare, LLC·20180524
Z-2192-2017 — GE Healthcare Discovery IQ X-ray systemClass II·Terminated·GE Healthcare, LLC·20170519

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141477.

Data sourced from openFDA. This site is unofficial and independent of the FDA.