Medrad Omniplane 300 System
FDA 510(k) K883834 · Medrad, Inc.
510(k) numberK883834
Submission
- Device name
- Medrad Omniplane 300 System
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- September 9, 1988
- Decision date
- November 4, 1988
- 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 |
|---|---|---|
| K133023 | Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6MCW · Traditional | 08/27/2014SE |
| K130381 | Angiojet Ultra Power Pulse KitQEW · Traditional | 07/29/2013SE |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…MCW · Special | 04/10/2013SE |
| K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…MCW · Special | 10/19/2012SE |
| K113363 | Angiojet Solent Dista Thrombectomy SetQEZ · Traditional | 06/06/2012SE |
| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 12/15/2011SE |
| K113428 | Angiojet Ultra DVX Thrombectomy SetQEZ · Special | 12/02/2011SE |
| K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 10/14/2011SE |
| K111182 | Angiojet Solent Omni Thrombectomy SetQEZ · Special | 05/24/2011SE |
| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | 06/23/2010SE |
Questions and answers
When was Medrad Omniplane 300 System cleared by the FDA?
Medrad Omniplane 300 System (K883834) received a 510(k) decision of Substantially Equivalent on November 4, 1988, 56 days after the submission was received.
What is the product code of K883834?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.