Sii 360 MS
FDA 510(k) K945708 · Scott Imaging Intl., Inc.
510(k) numberK945708
Submission
- Device name
- Sii 360 MS
- Applicant
- Scott Imaging Intl., Inc.
Mobile, AL, US - Received
- November 21, 1994
- Decision date
- December 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
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More from Dk Medical Systems Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K946260 | NTBS-1417, 1436, TBS-1417IXY · Traditional | 03/31/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | 03/21/1995SE |
| K950040 | Sii 525 AprIZO · Traditional | 03/21/1995SE |
| K946262 | Euro, SCST, Sccft Atlas Radiologic TablesIXQ · Traditional | 02/15/1995SE |
| K946261 | MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000IYB · Traditional | 02/15/1995SE |
| K945709 | Sii 525 MSKPR · Traditional | 12/14/1994SE |
Questions and answers
When was Sii 360 MS cleared by the FDA?
Sii 360 MS (K945708) received a 510(k) decision of Substantially Equivalent on December 14, 1994, 23 days after the submission was received.
What is the product code of K945708?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.