AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
FDA 510(k) clearance K013826 · decided 2002-02-01
Clearance details
- K-number
- K013826
- Device name
- AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-19
- Decision date
- 2002-02-01
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Iselin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with recall (Z-1583-2015) | Siemens Medical Solutions USA, Inc | 2015-05-05 |
| Axiom Aristos FX and FX Plus System Intended use: Stationary x-ray system recall (Z-1959-2011) | Siemens Medical Solutions USA, Inc | 2011-04-12 |
| Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7 recall (Z-0163-2009) | Siemens Medical Solutions USA, Inc | 2008-10-20 |
| Axiom Aristos TX. Model number 58 94 873 Radiology system recall (Z-0988-05) | Siemens Medical Solutions USA, Inc | 2005-07-13 |
| Axiom Aristos MX/VX. Model number 58 95 003 recall (Z-0989-05) | Siemens Medical Solutions USA, Inc | 2005-07-13 |
| Axiom Aristos FX. Model number 74 14 803 recall (Z-0990-05) | Siemens Medical Solutions USA, Inc | 2005-07-13 |
| Axiom Aristos X-Ray System. recall (Z-0984-03) | Siemens Medical Solutions USA, Inc | 2003-07-08 |