Allegro Viewing Wand
FDA 510(k) K911783 · I.S.G. Technologies, Inc.
510(k) numberK911783
Submission
- Device name
- Allegro Viewing Wand
- Applicant
- I.S.G. Technologies, Inc.
Mississauga Ontario, CA - Received
- April 22, 1991
- Decision date
- April 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Allegro Viewing Wand cleared by the FDA?
Allegro Viewing Wand (K911783) received a 510(k) decision of Substantially Equivalent on April 7, 1994, 1,081 days after the submission was received.
What is the product code of K911783?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.