X-Ray Generator Model KX0-825
FDA 510(k) K771295 · Toshiba Medical Systems
510(k) numberK771295
Submission
- Device name
- X-Ray Generator Model KX0-825
- Applicant
- Toshiba Medical Systems
Mchenry, IL, US - Received
- June 9, 1977
- Decision date
- August 3, 1977
- 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 |
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| K960948 | Scatter Correction Volume Software Model NSSC-020AKPS · Traditional | 12/23/1996SE |
| K954310 | BLA-800AKPW · Traditional | 10/18/1995SE |
| K954309 | AngiorexIZI · Traditional | 10/06/1995SE |
| K893750 | MRT-50A MobileLNH · Traditional | 08/09/1989SE |
| K891453 | Diagnostic Ultrasound Transducer: PVE-582VIYO · Traditional | 06/01/1989SE |
| K890969 | Transesophageal Transducer PEF-511SAIYO · Traditional | 05/16/1989SE |
| K884788 | Toshiba TCT-600XT Computed Tomography X-Ray SystemJAK · Traditional | 02/27/1989SE |
| K884555 | TCT-600HQ Compu Tomo(Ct)Xray/Head/Whole Body ExamJAK · Traditional | 02/27/1989SE |
| K883359 | Diagnostic Ultrasound System SSA-270AIYO · Traditional | 01/25/1989SE |
| K883756 | Toshiba MRT-50A Magnetic Resonance SystemLNH · Traditional | 11/14/1988SE |
Questions and answers
When was X-Ray Generator Model KX0-825 cleared by the FDA?
X-Ray Generator Model KX0-825 (K771295) received a 510(k) decision of Substantially Equivalent on August 3, 1977, 55 days after the submission was received.
What is the product code of K771295?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.