Siemens Polydoros 800
FDA 510(k) K820112 · Siemens Corp.
510(k) numberK820112
Submission
- Device name
- Siemens Polydoros 800
- Applicant
- Siemens Corp.
Walker, MI, US - Received
- January 15, 1982
- Decision date
- February 24, 1982
- 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 |
|---|---|---|
| K150843 | syngo®.via (version VB10A)LLZ · Abbreviated | 04/24/2015SE |
| K123375 | Syngo.ViaLLZ · Traditional | 11/20/2012SE |
| K110366 | Syngo.Ct Cardiac FunctionJAK · Traditional | 04/12/2011SE |
| K103360 | Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional | 12/17/2010SE |
| K081182 | Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible…JWY · Traditional | 08/08/2008SE |
| K071310 | Syngo CT Oncology Software PackageJAK · Traditional | 06/08/2007SE |
| K063507 | Syngo Neuro PBV CTJAK · Traditional | 11/30/2006SE |
| K063373 | Flex Loop Coil Set 3TMOS · Traditional | 11/17/2006SE |
| K053024 | Syngo Neuro Dsa CTJAK · Traditional | 11/04/2005SE |
| K050867 | Syngo Body Perfusion-CtJAK · Traditional | 04/14/2005SE |
Questions and answers
When was Siemens Polydoros 800 cleared by the FDA?
Siemens Polydoros 800 (K820112) received a 510(k) decision of Substantially Equivalent on February 24, 1982, 40 days after the submission was received.
What is the product code of K820112?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.