FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMALUX NIRIS IMAGING SYSTEM
K Number: K042894
·
Decision Nov 19, 2004
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- IMALUX NIRIS IMAGING SYSTEM
- K Number
- K042894
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imalux Corporation
- Date Received
- October 20, 2004
- Decision Date
- November 19, 2004
- 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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Other Clearances by Imalux Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K041077 | IMALUX OCT PROBE GUIDE | Jun 25, 2004 | Substantially Equivalent |