iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
FDA 510(k) K221081 · First Source, Inc.
510(k) numberK221081
Submission
- Device name
- iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
- Applicant
- First Source, Inc.
Rochester, NY, US - Received
- April 12, 2022
- Decision date
- June 13, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System cleared by the FDA?
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System (K221081) received a 510(k) decision of Substantially Equivalent on June 13, 2022, 62 days after the submission was received.
What is the product code of K221081?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.