Compact-X
FDA 510(k) K950694 · Electromed Intl., Ltd.
510(k) numberK950694
Submission
- Device name
- Compact-X
- Applicant
- Electromed Intl., Ltd.
St-Eustache, Quebec, CA - Received
- February 14, 1995
- Decision date
- March 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K950291 | Digital 625HFIZO · Traditional | Fischer Imaging Corp. | 03/23/1995SE |
| K950041 | Sii 360 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
| K950040 | Sii 525 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 |
|---|---|---|
| K003688 | View Reading StationLLZ · Abbreviated | 01/22/2001SE |
| K000474 | View NTLLZ · Abbreviated | 04/19/2000SE |
| K990759 | View ComLLZ · Abbreviated | 04/15/1999SE |
| K974255 | Cd-R Station and VRS-2000LMD · Traditional | 01/27/1998SE |
| K971176 | View Archiving StationIZI · Traditional | 09/03/1997SE |
| K880050 | Edec 60RIZO · Traditional | 02/29/1988SE |
| K875341 | Edec 60 R/FIZO · Traditional | 02/01/1988SE |
| K875342 | Edec 90CIZO · Traditional | 01/29/1988SE |
| K871145 | Edec 50C Constant Potential X-Ray GeneratorIZO · Traditional | 03/31/1987SE |
| K870851 | Edec 80 Constant Potential X-Ray GeneratorIZO · Traditional | 03/20/1987SE |
Questions and answers
When was Compact-X cleared by the FDA?
Compact-X (K950694) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 45 days after the submission was received.
What is the product code of K950694?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.