Modification to 3.0T Signa Vh/I Magnetic Resonance System
FDA 510(k) K003575 · GE Medical Systems
510(k) numberK003575
Submission
- Device name
- Modification to 3.0T Signa Vh/I Magnetic Resonance System
- Applicant
- GE Medical Systems
Milwaukee, WI, US - Received
- November 20, 2000
- Decision date
- January 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code LNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093044 | Oasis MRI SystemLNI · Traditional | Hitachi Medical Systems America, Inc. | 03/16/2010SE |
| K071506 | Echelon Spectroscopy PackageLNI · Abbreviated | Hitachi Medical Systems America, Inc. | 06/28/2007SE |
| K011604 | Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MRILNI · Traditional | Ge Medical Systems, Inc. | 08/22/2001SE |
| K010129 | Excelart with Pianissimo, Model MRT-1500/P3LNI · Traditional | Toshiba America Medical Systems, In.C | 04/05/2001SE |
| K991568 | MR Spectroscopy PackageLNI · Traditional | Philips Medical Systems (Cleveland), Inc. | 07/19/1999SE |
| K984167 | Sage 7LNI · Traditional | GE Medical Systems | 01/12/1999SE |
| K962627 | Clinical Phosphorus Spectroscopy Option/Magnetom Vision SystemLNI · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1997SE |
| K970005 | Gyrex 2T-PRESTIGELNI · Traditional | Elscint, Inc. | 03/28/1997SE |
| K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HTLNI · Traditional | GE Medical Systems | 04/25/1995SE |
More from GE Medical Systems
| 510(k) | Device | Decision |
|---|---|---|
| K253808 | AIR Recon DLLNH · Traditional | 08/13/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | 06/24/2026SE |
| K253502 | Critical Care Suite with Enteric Tube Positioning AI AlgorithmQIH · Traditional | 04/14/2026SE |
| K253520 | Photonova Spectra, Photonova Spectra SelectJAK · Traditional | 03/20/2026SE |
| K253780 | SIGNA BoltLNH · Traditional | 02/06/2026SE |
| K253779 | SIGNA Sprint SelectLNH · Traditional | 02/05/2026SE |
| K252379 | AIR Recon DLLNH · Traditional | 12/23/2025SE |
| K251399 | SIGNA SprintLNH · Traditional | 09/11/2025SE |
| K250941 | Revolution VibeJAK · Traditional | 08/01/2025SE |
| K243667 | Sonic DLLNH · Traditional | 06/05/2025SE |
Questions and answers
When was Modification to 3.0T Signa Vh/I Magnetic Resonance System cleared by the FDA?
Modification to 3.0T Signa Vh/I Magnetic Resonance System (K003575) received a 510(k) decision of Substantially Equivalent on January 17, 2001, 58 days after the submission was received.
What is the product code of K003575?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.