FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K Number: K053009
·
Decision Nov 17, 2005
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
169
Review Days
22
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
- GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
- K Number
- K053009
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems
- Date Received
- October 26, 2005
- Decision Date
- November 17, 2005
- 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 GE Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K220851 | Venue | Jun 27, 2022 | Substantially Equivalent |
| K220848 | Venue Fit | Jun 27, 2022 | Substantially Equivalent |
| K173341 | Vivid E80, Vivid E90, Vivid E95 | Nov 2, 2017 | Substantially Equivalent |
| K103411 | IDEAL IQ SOFTWARE OPTION | Mar 22, 2011 | Substantially Equivalent |
| K073138 | CARDIQ EXPRESS VERSION 2.0 | Feb 26, 2008 | Substantially Equivalent |
| K052434 | HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA | Sep 27, 2005 | Substantially Equivalent |
| K051673 | XELERIS 2 PROCESSING AND REVIEW WORKSTATION | Jul 18, 2005 | Substantially Equivalent |
| K051449 | GE VIVID 7 WITH OR WITHOUT SUFFIX | Jun 16, 2005 | Substantially Equivalent |
| K050559 | GE DISCOVERY VCT SYSTEM | Mar 17, 2005 | Substantially Equivalent |
| K042694 | ADVANCED LUNG ANALYSIS II | Nov 18, 2004 | Substantially Equivalent |