SIGNA Artist Evo

FDA 510(k) K213603 · Ge Healthcare (Tianjin) Company Limited

Substantially Equivalent

510(k) numberK213603

Submission

Device name
SIGNA Artist Evo
Applicant
Ge Healthcare (Tianjin) Company Limited
Tianjin, CN
Received
November 15, 2021
Decision date
February 11, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

Other 510(k)s with product code LNH

510(k)DeviceApplicantDecision
K260758MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional Siemens Shenzhen Magnetic Resonance , Ltd.09/01/2026SE
K262622Swoop® Portable MR Imaging® SystemLNH · Special Hyperfine, Inc.08/19/2026SE
K254250MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional Xingaoyi Medical Equipment Co.,Ltd08/17/2026SE
K253808AIR Recon DLLNH · Traditional GE Medical Systems08/13/2026SE
K261331I-Genius (100019400)LNH · Traditional Esaote, S.p.A.07/31/2026SE
K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional Siemens Healthineers AG07/31/2026SE
K260113uMR AstraLNH · Traditional Shanghai United Imaging Healthcare Co., Ltd.05/22/2026SE
K253862APERTO Lucent MRI SystemLNH · Traditional Fujifilm Corporation04/06/2026SE
K260746S-scan Open (100001800)LNH · Special Esaote, S.p.A.03/27/2026SE
K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional Canon Medical Systems Corporation03/27/2026SE

More from Canon Medical Systems Corporation

510(k)DeviceDecision
K233728SIGNA ChampionLNH · Traditional 01/19/2024SE
K223439SIGNA VictorLNH · Traditional 02/13/2023SE
K211980SIGNA PrimeLNH · Traditional 01/16/2022SE
K202238SIGNA ArtistLNH · Special 09/04/2020SE
K192426Signa Voyager, Signa Voyager QuantumLNH · Special 10/01/2019SE

Questions and answers

When was SIGNA Artist Evo cleared by the FDA?

SIGNA Artist Evo (K213603) received a 510(k) decision of Substantially Equivalent on February 11, 2022, 88 days after the submission was received.

What is the product code of K213603?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.