G.E. Msi 850/850II/1250 Three Phase Generators
FDA 510(k) K902988 · Electromek Diagnostic Systems, Inc.
510(k) numberK902988
Submission
- Device name
- G.E. Msi 850/850II/1250 Three Phase Generators
- Applicant
- Electromek Diagnostic Systems, Inc.
Troy, IL, US - Received
- June 26, 1990
- Decision date
- December 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K950040 | Sii 525 AprIZO · Traditional | Scott Imaging Intl., Inc. | 03/21/1995SE |
More from Scott Imaging Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902986 | G.E. DXD 325/350/350II/DXD 525/525II GeneratorsIZO · Traditional | 02/13/1991SE |
| K902987 | G.E. DXS 350/550/650/650II Single Phase GeneratorsIZO · Traditional | 12/26/1990SE |
| K902985 | G.E. MST 625/625II/MST 1050/1050II Three Phase GenIZO · Traditional | 12/19/1990SE |
| K902982 | G.E. Polarix II C-ArmJAA · Traditional | 11/13/1990SE |
| K902981 | G.E. Fluorocon 300 Imaging SystemJAA · Traditional | 11/07/1990SE |
| K902983 | Siemen's Siremobile II C-ArmJAA · Traditional | 11/06/1990SE |
| K902989 | G.E. Monitrol 90 and G.E. Monitrol 15IXR · Traditional | 10/29/1990SE |
| K902791 | G.E. 48-4 Ceiling TubehangerKPR · Traditional | 10/29/1990SE |
| K902984 | G.E. Amx 110, Amx II and Amx 3 X-Ray UnitsIZL · Traditional | 10/26/1990SE |
| K902980 | G.E. XT Ceiling Tube SuspensionJAA · Traditional | 10/23/1990SE |
Questions and answers
When was G.E. Msi 850/850II/1250 Three Phase Generators cleared by the FDA?
G.E. Msi 850/850II/1250 Three Phase Generators (K902988) received a 510(k) decision of Substantially Equivalent on December 19, 1990, 176 days after the submission was received.
What is the product code of K902988?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.