Iluma Vision
FDA 510(k) K081347 · Imtec Corp.
510(k) numberK081347
Submission
- Device name
- Iluma Vision
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- May 14, 2008
- Decision date
- May 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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Questions and answers
When was Iluma Vision cleared by the FDA?
Iluma Vision (K081347) received a 510(k) decision of Substantially Equivalent on May 28, 2008, 14 days after the submission was received.
What is the product code of K081347?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.