FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K Number: K013826
·
Decision Feb 1, 2002
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
25
Review Days
74
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Basic Information
- Device Name
- AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
- K Number
- K013826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Systems, Inc.
- Date Received
- November 19, 2001
- Decision Date
- February 1, 2002
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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| 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 |