SR-130
FDA 510(k) K030494 · Source-Ray, Inc.
510(k) numberK030494
Submission
- Device name
- SR-130
- Applicant
- Source-Ray, Inc.
Bohemia, NY, US - Received
- February 19, 2003
- Decision date
- May 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K062472 | Optional Remote Control, Model RC-115, for Portable X-Ray System, Model SR-115IZL · Traditional | 10/31/2006SE |
| K052001 | Model SR-115 Portable X-Ray SystemIZL · Traditional | 08/11/2005SE |
| K043062 | Model SR-130-D Portable Digital X-Ray SystemIZL · Traditional | 12/13/2004SE |
Questions and answers
When was SR-130 cleared by the FDA?
SR-130 (K030494) received a 510(k) decision of Substantially Equivalent on May 20, 2003, 90 days after the submission was received.
What is the product code of K030494?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.