Multix U. Bucky Table X-Ray Unit
FDA 510(k) K803130 · Siemens Corp.
510(k) numberK803130
Submission
- Device name
- Multix U. Bucky Table X-Ray Unit
- Applicant
- Siemens Corp.
Walker, MI, US - Received
- December 12, 1980
- Decision date
- January 28, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260227 | EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS…KPR · Traditional | DRTECH Corporation | 09/08/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | Siemens Medical Solutions USA, Inc. | 08/31/2026SE |
| K260481 | GC85AKPR · Traditional | Samsung Electronics Co., Ltd. | 08/27/2026SE |
| K260482 | DRE DuoKPR · Traditional | Jpi Healthcare Co, Ltd. | 06/15/2026SE |
| K253446 | AeroDR TX c02KPR · Traditional | Dk Medical Systems Co., Ltd. | 04/10/2026SE |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…KPR · Traditional | Carestream Health | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 11/26/2025SE |
| K251167 | uDR Aurora CXKPR · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 09/19/2025SE |
| K250788 | Definium Tempo SelectKPR · Traditional | Ge Hualun Medical Systems Co. , Ltd. | 08/28/2025SE |
| K250790 | Innovision-DxiiKPR · Traditional | Dk Medical Systems Co., Ltd. | 08/01/2025SE |
More from Dk Medical Systems Co., Ltd.
| 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 Multix U. Bucky Table X-Ray Unit cleared by the FDA?
Multix U. Bucky Table X-Ray Unit (K803130) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 47 days after the submission was received.
What is the product code of K803130?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.