LifeRay Intraoral Handheld X-ray System
FDA 510(k) K241305 · Lucas Lifecare
510(k) numberK241305
Submission
- Device name
- LifeRay Intraoral Handheld X-ray System
- Applicant
- Lucas Lifecare
Janesville, WI, US - Received
- May 9, 2024
- Decision date
- July 5, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242591 | XERO-alphaEHD · Traditional | DRTECH Corporation | 11/01/2024SE |
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Questions and answers
When was LifeRay Intraoral Handheld X-ray System cleared by the FDA?
LifeRay Intraoral Handheld X-ray System (K241305) received a 510(k) decision of Substantially Equivalent on July 5, 2024, 57 days after the submission was received.
What is the product code of K241305?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.