FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAGNETOM Avantofit, MAGNETOM Skyrafit
K Number: K162102
·
Decision Nov 22, 2016
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
19
Review Days
116
Basic Information
- Device Name
- MAGNETOM Avantofit, MAGNETOM Skyrafit
- K Number
- K162102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS MEDICAL SOLUTIONS, INC.
- Date Received
- July 29, 2016
- Decision Date
- November 22, 2016
- 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 |
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Other Clearances by SIEMENS MEDICAL SOLUTIONS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K133643 | SYNGO, CT LIVER ANALYSIS | Nov 13, 2014 | Substantially Equivalent |
| K142628 | Acuson SC2000 Diagnostic Ultrasound System | Oct 10, 2014 | Substantially Equivalent |
| K132934 | MULTIX SELECT DR | Apr 10, 2014 | Substantially Equivalent |
| K132094 | CIOS ALPHA | Mar 11, 2014 | Substantially Equivalent |
| K131812 | SENSIS, SENSIS LITE | Jul 25, 2013 | Substantially Equivalent |
| K130754 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 25, 2013 | Substantially Equivalent |
| K121434 | SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO | Nov 5, 2012 | Substantially Equivalent |
| K112020 | SYNGO.CT VASCULAR ANALYSIS | Aug 18, 2011 | Substantially Equivalent |