Clinical Phosphorus Spectroscopy Option/Magnetom Vision System
FDA 510(k) K962627 · Siemens Medical Solutions USA, Inc.
510(k) numberK962627
Submission
- Device name
- Clinical Phosphorus Spectroscopy Option/Magnetom Vision System
- Applicant
- Siemens Medical Solutions USA, Inc.
Iselin, NJ, US - Received
- July 5, 1996
- Decision date
- April 3, 1997
- 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 |
| K003575 | Modification to 3.0T Signa Vh/I Magnetic Resonance SystemLNI · Traditional | GE Medical Systems | 01/17/2001SE |
| K991568 | MR Spectroscopy PackageLNI · Traditional | Philips Medical Systems (Cleveland), Inc. | 07/19/1999SE |
| K984167 | Sage 7LNI · Traditional | GE Medical Systems | 01/12/1999SE |
| 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 |
|---|---|---|
| K261696 | ACUNAV Luxera 4D ICE CatheterOBJ · Special | 09/10/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | 08/31/2026SE |
| K253786 | syngo.CT Coronary CockpitQIH · Traditional | 06/25/2026SE |
| K253678 | MAMMOMAT B.brilliant (11372950)MUE · Traditional | 06/18/2026SE |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | 06/16/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | 05/21/2026SE |
| K254184 | syngo Application SoftwareQIH · Traditional | 04/29/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | 04/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | 03/20/2026SE |
Questions and answers
When was Clinical Phosphorus Spectroscopy Option/Magnetom Vision System cleared by the FDA?
Clinical Phosphorus Spectroscopy Option/Magnetom Vision System (K962627) received a 510(k) decision of Substantially Equivalent on April 3, 1997, 272 days after the submission was received.
What is the product code of K962627?
The FDA product code is LNI – System, Nuclear Magnetic Resonance Spectroscopic, a Class II (moderate risk) device regulated under 21 CFR 892.1000.