Magnetom P8
by Siemens Medical Solutions USA, Inc.
510(k) K932338
Magnetom P8 is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K932338 on 30 Aug 1993, 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 | NumberK932338 | Date30 Aug 1993 | StatusActive |
Official records
- FDA 510(k) database K932338
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- Withdrawn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).
- GYROSCAN S15/ACS by Philips Medical Systems
- MRI Magnetic Resonance Analytical Software System by Medis Medical Imaging Systems bv
- ECHELON Synergy by FUJIFILM CORPORATION
- Sat Pad by Alliance Pharmaceutical Corp.
- MRINNERVU Disposable Endorectal Colon Coil, #PCC-15 by Medrad, Inc.
- SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM by Shimadzu Medical Systems
- OPTIMA MR450W by GE Medical Systems, LLC
- I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM by Wandong Medical
- GE SIGNA MR ONCOLOGY PACKAGE by GE Medical Systems, LLC
- MR-Guide 2000 by Ultraguide, Ltd.