SOMATOM EMOTION 6 CT SYSTEMS
FDA 510(k) clearance K023687 · decided 2002-11-22
Clearance details
- K-number
- K023687
- Device name
- SOMATOM EMOTION 6 CT SYSTEMS
- Applicant
- Siemens Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-01
- Decision date
- 2002-11-22
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- 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 |
|---|---|---|
| SOMATOM Emotion 6 (Model 10165888) recall (Z-2472-2018) | Siemens Medical Solutions USA, Inc | 2018-03-30 |
| SOMATOM Emotion 16 (10165977) recall (Z-2473-2018) | Siemens Medical Solutions USA, Inc | 2018-03-30 |
| Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Prod recall (Z-1721-2014) | Siemens Medical Solutions USA, Inc | 2014-06-04 |
| SOMATOM Emotion 6. Computed tomography X-ray system recall (Z-2452-2008) | Siemens Medical Solutions USA, Inc | 2008-09-21 |
| SOMATOM CT System Emotion 6, Computed Tomography X-Ray System, Model Number: 38 15 490 recall (Z-0157-05) | Siemens Medical Solutions USA, Inc | 2004-11-03 |