Sii 525 Apr
FDA 510(k) K950040 · Scott Imaging Intl., Inc.
510(k) numberK950040
Submission
- Device name
- Sii 525 Apr
- Applicant
- Scott Imaging Intl., Inc.
Mobile, AL, US - Received
- January 5, 1995
- Decision date
- March 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954666 | MPH50, MPH65, and MPH80IZO · Traditional | GE Medical Systems | 11/24/1995SE |
| K953582 | HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional | Varian Canada, Inc. | 09/26/1995SE |
| K953831 | N 800 HFIZO · Traditional | Nucletron-Oldelft Corp. | 09/08/1995SE |
| K952822 | Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional | Shimadzu Corp. | 07/12/1995SE |
| K952265 | Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional | Control-X, Inc. | 07/06/1995SE |
| K950883 | Polydoros SX 65 and 80IZO · Traditional | Siemens Medical Solutions USA, Inc. | 04/03/1995SE |
| K950694 | Compact-XIZO · Traditional | Electromed Intl., Ltd. | 03/31/1995SE |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K945453 | Ud 150L-R IIIZO · Traditional | Shimadzu Medical Systems | 03/21/1995SE |
More from Shimadzu Medical Systems
| 510(k) | Device | Decision |
|---|---|---|
| K946260 | NTBS-1417, 1436, TBS-1417IXY · Traditional | 03/31/1995SE |
| K950041 | Sii 360 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 |
| K945708 | Sii 360 MSKPR · Traditional | 12/14/1994SE |
Questions and answers
When was Sii 525 Apr cleared by the FDA?
Sii 525 Apr (K950040) received a 510(k) decision of Substantially Equivalent on March 21, 1995, 75 days after the submission was received.
What is the product code of K950040?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.