LNH · System, Nuclear Magnetic Resonance Imaging

Device class

Class II

Regulation 892.1000

Total clearances

192

2020-01-06 → 2026-09-16

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1000

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Canon Medical Systems Corporation	26	1	2026-03-27
Siemens Medical Solutions USA, Inc.	23	0	2024-03-29
Shanghai United Imaging Healthcare Co., Ltd.	16	1	2026-05-22
Hyperfine, Inc.	12	2	2026-08-19
Philips Medical Systems Nederland B.V.	10	1	2026-02-23
Ge Medical Systems, LLC	10	4	2026-08-13
Perspectum, Ltd.	5	1	2026-03-09
Esaote, S.p.A.	5	3	2026-07-31
Ge Healthcare (Tianjin) Company Limited	5	0	2024-01-19
Siemens Shenzhen Magnetic Resonance , Ltd.	4	3	2026-09-01
Fujifilm Healthcare Corporation	4	0	2024-08-13
Hitachi Healthcare Americas	3	0	2021-10-07
Ge Healthcare (Ge Medical Systems, LLC)	3	0	2022-01-20
Fujifilm Corporation	3	2	2026-09-16
FUJIFILM Healthcare Americas Corporation	2	0	2024-05-10
Ge Medical Systems,Llc (Ge Healthcare)	2	0	2023-05-30
Hyperfine Research, Inc.	2	0	2020-08-11
Nordicneurolab AS	2	1	2026-03-20
Ivy Biomedical Systems, Inc.	2	0	2021-03-02
Siemens Healthcare GmbH	2	1	2025-12-19
Resonance Health Analysis Services Pty, Ltd.	2	0	2023-06-20
Deerfield Imaging, Inc.	2	0	2024-02-15
Aspect Imaging, Ltd.	2	2	2026-09-16
Spintech, Inc.	2	0	2022-10-28
Syntheticmr AB	2	0	2021-11-03

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
70553	CPT	—	High	Magnetic resonance imaging; NMR imaging system professional service

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-16	K261758	Aspect Imaging, Ltd.	Embrace Vision Neonatal MRI System
2026-09-16	K261283	Fujifilm Corporation	APERTO Lucent MRI System
2026-09-01	K260758	Siemens Shenzhen Magnetic Resonance , Ltd.	MAGNETOM Free.Max; MAGNETOM Free.Star
2026-08-19	K262622	Hyperfine, Inc.	Swoop® Portable MR Imaging® System
2026-08-17	K254250	Xingaoyi Medical Equipment Co.,Ltd	MagicScan-1.5, GreenMR Serenity 1.5T
2026-08-13	K253808	GE Medical Systems	AIR Recon DL
2026-07-31	K261331	Esaote, S.p.A.	I-Genius (100019400)
2026-07-31	K260852	Siemens Healthineers AG	MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
2026-05-22	K260113	Shanghai United Imaging Healthcare Co., Ltd.	uMR Astra
2026-04-06	K253862	Fujifilm Corporation	APERTO Lucent MRI System
2026-03-27	K260746	Esaote, S.p.A.	S-scan Open (100001800)
2026-03-27	K253625	Canon Medical Systems Corporation	Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
2026-03-20	K251937	Nordicneurolab AS	nordicAudio (1.0)
2026-03-13	K254277	Aspect Imaging, Ltd.	Embrace Neonatal MRI System
2026-03-09	K253413	Perspectum, Ltd.	LiverMultiScan (v6.0)
2026-03-05	K251901	Esaote, S.p.A.	Magnifico Open (100009900)
2026-02-23	K260265	Siemens Shenzhen Magnetic Resonance , Ltd.	MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
2026-02-23	K253648	Philips Medical Systems Nederland B.V.	Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
2026-02-06	K253780	Ge Medical Systems, LLC	SIGNA Bolt
2026-02-05	K253779	Ge Medical Systems, LLC	SIGNA Sprint Select
2026-01-26	K253499	Eyas Medical Imaging, Inc.	Ascent3T Neonatal Magnetic Resonance Imaging System
2025-12-23	K252379	Ge Medical Systems, LLC	AIR Recon DL
2025-12-19	K252838	Siemens Healthcare GmbH	MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
2025-12-12	K253489	Hyperfine, Inc.	Swoop® Portable MR Imaging® System
2025-11-20	K251822	Siemens Shenzhen Magnetic Resonance , Ltd.	MAGNETOM Free.Max; MAGNETOM Free.Star