FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
K Number: K071403
·
Decision Jun 11, 2007
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
19
Review Days
21
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Basic Information
- Device Name
- X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
- K Number
- K071403
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imaging Dynamics Company , Ltd.
- Date Received
- May 21, 2007
- Decision Date
- June 11, 2007
- Product Code
- KPR
- 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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| K170202 | Aquarius 8600 | Feb 22, 2017 | Substantially Equivalent |
| K111098 | INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN | May 27, 2011 | Substantially Equivalent |
| K071401 | X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM | Jun 22, 2007 | Substantially Equivalent |
| K071408 | X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR | Jun 13, 2007 | Substantially Equivalent |
| K071402 | X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM | Jun 8, 2007 | Substantially Equivalent |
| K071409 | X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM | Jun 8, 2007 | Substantially Equivalent |
| K070079 | X3C DIGITAL RADIOGRAPHIC DETECTOR | Jan 31, 2007 | Substantially Equivalent |