FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNIA X/XS ULTRASOUND SYSTEM
K Number: K020353
·
Decision Feb 13, 2002
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
25
Review Days
9
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Basic Information
- Device Name
- OMNIA X/XS ULTRASOUND SYSTEM
- K Number
- K020353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Systems, Inc.
- Date Received
- February 4, 2002
- Decision Date
- February 13, 2002
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA Class 2
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Other Clearances by Siemens Medical Systems, Inc.
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|---|---|---|---|
| K133646 | ADMIRE | Jun 20, 2014 | Substantially Equivalent |
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| 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 |
| K122471 | SOMATOM DEFINITION | Sep 11, 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 |