FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORESEE (4C) IMAGING SYSTEM
K Number: K133209
·
Decision Mar 17, 2014
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
1
Review Days
151
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Basic Information
- Device Name
- FORESEE (4C) IMAGING SYSTEM
- K Number
- K133209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diagnostic Photonics, Inc.
- Date Received
- October 17, 2013
- Decision Date
- March 17, 2014
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | FDA class 2 | Radiology |
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