Optional Remote Control, Model RC-115, for Portable X-Ray System, Model SR-115
FDA 510(k) K062472 · Source-Ray, Inc.
510(k) numberK062472
Submission
- Device name
- Optional Remote Control, Model RC-115, for Portable X-Ray System, Model SR-115
- Applicant
- Source-Ray, Inc.
Bohemia, NY, US - Received
- August 24, 2006
- Decision date
- October 31, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Optional Remote Control, Model RC-115, for Portable X-Ray System, Model SR-115 cleared by the FDA?
Optional Remote Control, Model RC-115, for Portable X-Ray System, Model SR-115 (K062472) received a 510(k) decision of Substantially Equivalent on October 31, 2006, 68 days after the submission was received.
What is the product code of K062472?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.