FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMATOM DEFINITION
K Number: K122471
·
Decision Sep 11, 2012
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
25
Review Days
28
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Basic Information
- Device Name
- SOMATOM DEFINITION
- K Number
- K122471
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Systems, Inc.
- Date Received
- August 14, 2012
- Decision Date
- September 11, 2012
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by Siemens Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133646 | ADMIRE | Jun 20, 2014 | Substantially Equivalent |
| K130901 | SOMATOM DEFINITION AS OPEN | Jan 2, 2014 | Substantially Equivalent |
| K123540 | SYNGO CT PULMO 3D | Aug 29, 2013 | Substantially Equivalent |
| K123541 | SYNGO.CT NEURO PERFUSION | Apr 2, 2013 | Substantially Equivalent |
| K122909 | SYNGO SINGLE SOURCE DUAL ENGERY | Dec 27, 2012 | Substantially Equivalent |
| K120579 | SOMATOM DEFINITION EDGE | May 23, 2012 | Substantially Equivalent |
| K121072 | SOMATOM DEFINITION FLASH | May 8, 2012 | Substantially Equivalent |
| K113342 | SOMATOM DEFINITION FLASH | Dec 29, 2011 | Substantially Equivalent |
| K052216 | SOMATOM DEFINITION | Sep 8, 2005 | Substantially Equivalent |
| K051602 | AXIOM SIRESKOP SD | Jul 7, 2005 | Substantially Equivalent |