XRT 400
FDA 510(k) K955414 · Wuestec Medical, Inc.
510(k) numberK955414
Submission
- Device name
- XRT 400
- Applicant
- Wuestec Medical, Inc.
Mobile, AL, US - Received
- November 27, 1995
- Decision date
- July 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Continental X-Ray Corp.
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|---|---|---|
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| K981880 | DX-480, Add on Digital ImagerKPR · Traditional | 10/20/1998SE |
| K974240 | Lightline-MIZX · Traditional | 12/22/1997SE |
| K960083 | Movable Cantilevered Radiographic Table XRT 100, 200 & 300IXQ · Traditional | 07/24/1996SE |
| K935123 | Superstand 300IYB · Traditional | 03/27/1996SE |
| K933253 | Superstand 3000IYB · Traditional | 08/16/1993SE |
Questions and answers
When was XRT 400 cleared by the FDA?
XRT 400 (K955414) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 240 days after the submission was received.
What is the product code of K955414?
The FDA product code is KXJ – Table, Radiologic, a Class II (moderate risk) device regulated under 21 CFR 892.1980.