Simtec Im-Maxx 2 Option
by Siemens Medical Solutions USA, Inc.
510(k) K052315
Simtec Im-Maxx 2 Option is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K052315 on 22 Sep 2005, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052315 | Date22 Sep 2005 | StatusActive |
Official records
- FDA 510(k) database K052315
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).
- GYREX 2T-SGR by Elscint, Inc.
- VANTAGE TITAN 3T by Toshiba Medical Systems
- DYNAWELL OR DYNAWELL by Ekeroth Quality AB
- EXCELART WITH PIANISSIMO by Toshiba America Mri, Inc.
- Magnetic Reasonance Imaging System by Jiangsu Magspin Instrument Co., Ltd
- Magniscan 5000 MRI System by Thomson-Cgr Medical Corp.
- ORTHOVU-1000 by Magnevu
- MODEL 405GE-64: PHASED ARRAY TMJ COIL by Medical Advances, Inc.
- GE MR MAX SYSTEM by General Electric Co.
- OASIS MRI System by Hitachi Healthcare Americas Corporation