FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Artis zee/zeego & Artis Q/Q.zen
K Number: K181407
·
Decision Aug 15, 2018
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
8
Review Days
77
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Basic Information
- Device Name
- Artis zee/zeego & Artis Q/Q.zen
- K Number
- K181407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medical Solution USA, Inc.
- Date Received
- May 30, 2018
- Decision Date
- August 15, 2018
- Product Code
- OWB
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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| K163285 | syngo Application Software | Feb 14, 2017 | Substantially Equivalent |