FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMRX
K Number: K091166
·
Decision Sep 2, 2009
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
14
Review Days
133
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IMRX
- K Number
- K091166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imris, Inc.
- Date Received
- April 22, 2009
- Decision Date
- September 2, 2009
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNH), ordered by most recent decision date.
uMR Astra
FDA 510(k)
FDA Class 2
·Radiology
APERTO Lucent MRI System
FDA 510(k)
FDA Class 2
·Radiology
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
FDA 510(k)
FDA Class 2
·Radiology
S-scan Open (100001800)
FDA 510(k)
FDA Class 2
·Radiology
nordicAudio (1.0)
FDA 510(k)
FDA Class 2
·Radiology
Embrace Neonatal MRI System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Imris, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K143420 | SYMBIS Surgical System | Oct 30, 2015 | Substantially Equivalent |
| K141950 | HFD100 ROCKER ARM ACCESSORY | Sep 4, 2014 | Substantially Equivalent |
| K133692 | IMRI 1.5T AND IMRI 3T S | Feb 10, 2014 | Substantially Equivalent |
| K130224 | ICT | Jul 18, 2013 | Substantially Equivalent |
| K123091 | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T | Dec 27, 2012 | Substantially Equivalent |
| K121997 | IMRIS ONCOLOGY PACKAGE | Aug 10, 2012 | Substantially Equivalent |
| K113748 | IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) | Mar 23, 2012 | Substantially Equivalent |
| K103493 | HEAD FIATION DEVICE (HFD 100) | Mar 11, 2011 | Substantially Equivalent |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | Feb 2, 2011 | Substantially Equivalent |
| K101813 | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO | Oct 5, 2010 | Substantially Equivalent |