The Roboguide
FDA 510(k) K961849 · Shai Syg Motion and Innovations, Ltd.
510(k) numberK961849
Submission
- Device name
- The Roboguide
- Applicant
- Shai Syg Motion and Innovations, Ltd.
Efrat, IL - Received
- May 13, 1996
- Decision date
- August 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was The Roboguide cleared by the FDA?
The Roboguide (K961849) received a 510(k) decision of Substantially Equivalent on August 21, 1996, 100 days after the submission was received.
What is the product code of K961849?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.