MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000
FDA 510(k) K946261 · Scott Imaging Intl., Inc.
510(k) numberK946261
Submission
- Device name
- MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000
- Applicant
- Scott Imaging Intl., Inc.
Mobile, AL, US - Received
- December 13, 1994
- Decision date
- February 15, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IYB
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|---|---|---|---|
| K935123 | Superstand 300IYB · Traditional | Wuestec Medical, Inc. | 03/27/1996SE |
| K941017 | F/C/W TubestandIYB · Traditional | Acoma Medical Imaging, Inc. | 07/29/1994SE |
| K941004 | CTS SystemIYB · Traditional | Acoma Medical Imaging, Inc. | 07/29/1994SE |
| K940442 | MPR-814IYB · Traditional | Xri, Inc. | 06/09/1994SE |
| K935004 | Model Alpha TS-2IYB · Traditional | Dpa Consulting, Inc. | 12/13/1993SE |
| K933253 | Superstand 3000IYB · Traditional | Wuestec Medical, Inc. | 08/16/1993SE |
| K925716 | Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional | Bennett X-Ray Corp. | 12/17/1992SE |
| K925170 | Shimadzu X-Ray Tube Stand BH-100 SeriesIYB · Traditional | Shimadzu Medical Systems | 12/07/1992SE |
| K920727 | Ceiling Tube Support CH-30XIYB · Traditional | Shimadzu Medical Systems | 04/16/1992SE |
| K914944 | Bennett Overhead Tube Crane Model No. B-OtcIYB · Traditional | Bennett X-Ray Corp. | 12/02/1991SE |
More from Bennett X-Ray Corp.
| 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 |
| K945709 | Sii 525 MSKPR · Traditional | 12/14/1994SE |
| K945708 | Sii 360 MSKPR · Traditional | 12/14/1994SE |
Questions and answers
When was MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000 cleared by the FDA?
MTS-007, STS-008, SSMTS-010, EURO-40, 72, Super Euro 4072, 5000 (K946261) received a 510(k) decision of Substantially Equivalent on February 15, 1995, 64 days after the submission was received.
What is the product code of K946261?
The FDA product code is IYB – Tube Mount, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1770.