SIGNA PET/MR— 510(k) K213709

Substantially Equivalent

Ge Medical Systems, LLC

FDA 510(k) clearance K213709 for SIGNA PET/MR, Substantially Equivalent on 2022-01-20. Applicant: Ge Medical Systems, LLC. Device class: 2.

Clearance details

Applicant: Ge Medical Systems, LLC
Product code: Code OUO
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2021-11-24
Decision date: 2022-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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K222540 — uPMR 7902022-11-14
K200213 — Biograph mMR with syngo MR E11P-AP01 system software2020-05-11

More clearances from Ge Medical Systems, LLC

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K253780 — SIGNA Bolt2026-02-06
K253779 — SIGNA Sprint Select2026-02-05

Recalls naming K213709

K-number listed on FDA's recall record

Z-2309-2025 — GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic ResonanceClass II·Ongoing·GE Medical Systems, LLC·20250620
Z-0520-2025 — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,Class II·Ongoing·GE Medical Systems, LLC·20241028
Z-2466-2024 — SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonanceClass II·Ongoing·GE Medical Systems, LLC·20240614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213709.

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