FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZIEHM QUANTUM
K Number: K051064
·
Decision May 26, 2005
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
7
Review Days
30
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Basic Information
- Device Name
- ZIEHM QUANTUM
- K Number
- K051064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ziehm Imaging, Inc.
- Date Received
- April 26, 2005
- Decision Date
- May 26, 2005
- 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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Other Clearances by Ziehm Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K092438 | ZIEHM SOLO | Dec 23, 2009 | Substantially Equivalent |
| K083545 | ZIEHM VISION RFD | May 15, 2009 | Substantially Equivalent |
| K073346 | ZIEHM VISION 2 | Mar 21, 2008 | Substantially Equivalent |
| K061310 | ZIEHM VARIO 3D DIGITAL MOBILE IMAGING SYSTEM | Jul 7, 2006 | Substantially Equivalent |
| K061534 | ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM | Jul 7, 2006 | Substantially Equivalent |
| K061203 | ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM | Jun 19, 2006 | Substantially Equivalent |