Imalux Niris Imaging System
FDA 510(k) K042894 · Imalux Corporation
510(k) numberK042894
Submission
- Device name
- Imalux Niris Imaging System
- Applicant
- Imalux Corporation
Cleveland, OH, US - Received
- October 20, 2004
- Decision date
- November 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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More from Gentuity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K041077 | Imalux Oct Probe GuideKKX · Traditional | 06/25/2004SE |
Questions and answers
When was Imalux Niris Imaging System cleared by the FDA?
Imalux Niris Imaging System (K042894) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 30 days after the submission was received.
What is the product code of K042894?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.