SIGNA Prime— 510(k) K211980

Clearance details

Applicant

Ge Healthcare (Tianjin) Company Limited

Product code

Code LNH

Device class

Class 2

Regulation

21 CFR 892.1000

Advisory panel

Radiology

Date received

2021-06-25

Decision date

2022-01-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tianjin, CN

• K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
• K262622 — Swoop® Portable MR Imaging® System2026-08-19
• K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
• K253808 — AIR Recon DL2026-08-13
• K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

• K233728 — SIGNA Champion2024-01-19
• K223439 — SIGNA Victor2023-02-13
• K213603 — SIGNA Artist Evo2022-02-11
• K202238 — SIGNA Artist2020-09-04
• K192426 — Signa Voyager, Signa Voyager Quantum2019-10-01

Death

11

Injury

670

Malfunction

1,460

Other

2

Total

2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2479-2024 — SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging SystemClass II·Ongoing·GE Medical Systems, LLC·20240614
• Z-0983-2022 — GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA PET/MR, 1.5T SIGNA Creator, 1.5T SIGNA Explorer, 1.5T SIGNA MR355, 1.5T SIGNA MR360, 1.49T SIGNA MR380, SIGNA Voyager, SIGNA Voyager Premier Edition, SIGNA Artist, Optima MR450w 1.5T, Optima MR450w GEM, Discovery MR450 1.5T, GE 1.5T and 3.0T SIGNA HDx, GE 1.5T and 3.0T SIGNA HDxt, 1.5T and 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant, SIGNA 1.5T TwinSpeed, SIGNA Infinity Excite, SIGNA Infinity with Excite Technology, SIGNA OpenSpeed, SIGNA HFO, SIGNA HFO/I MR System, GE 0.7T SIGNA OpenSpeed, SIGNA OpenSpeed with Excite, SIGNA HDe, Brivo MR355, Optima MR360, SIGNA 3.0T MR System, SIGNA Excite 3T, 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD, SIGNA Contour, SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, HighSpeed Plus, MR Vectra, MR MAX, Optima MR430s, Optima MR430s 1.5T, Optima MR430s MRI Scanner, 1.0T MSK Extreme, SIGNA Profile EXCITE, SIGNA Ovation, 0.35T SIGNA Ovation with Excite, SIGNA Prime.Class II·Ongoing·GE Healthcare, LLC·20220304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211980.