XR-910
FDA 510(k) K981466 · Imaging Sciences Intl., Inc.
510(k) numberK981466
Submission
- Device name
- XR-910
- Applicant
- Imaging Sciences Intl., Inc.
Roebling, NJ, US - Received
- April 23, 1998
- Decision date
- July 14, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was XR-910 cleared by the FDA?
XR-910 (K981466) received a 510(k) decision of Substantially Equivalent on July 14, 1998, 82 days after the submission was received.
What is the product code of K981466?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.