Neuro Vision Radiographic X-Ray System
FDA 510(k) K904146 · Mallinckrodt Group, Inc.
510(k) numberK904146
Submission
- Device name
- Neuro Vision Radiographic X-Ray System
- Applicant
- Mallinckrodt Group, Inc.
Cincinnati, OH, US - Received
- September 7, 1990
- Decision date
- December 13, 1990
- 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 |
|---|---|---|
| K945053 | LF CT Hig Pressure CathetersFOZ · Traditional | 05/19/1995SE |
| K945140 | Uro-FloLJH · Traditional | 03/08/1995SE |
| K943581 | Hydradjust IV Urological TableIXR · Traditional | 01/04/1995SE |
| K943122 | Surgical DrapesKKX · Traditional | 09/07/1994SE |
| K934664 | HydragownFYA · Traditional | 05/24/1994SE |
| K920742 | Hydrajust IV Urological TableIXR · Traditional | 04/27/1992SE |
| K912944 | CT 8000 Digital Injection SystemDXT · Traditional | 02/04/1992SE |
| K913264 | Hydraview 1000 Digital Image Process/Stor DeviceLLZ · Traditional | 11/01/1991SE |
| K905789 | Franklin 9000 Wall StandKPX · Traditional | 05/20/1991SE |
| K904147 | Hugh Young II Urological X-Ray SystemKPR · Traditional | 12/13/1990SE |
Questions and answers
When was Neuro Vision Radiographic X-Ray System cleared by the FDA?
Neuro Vision Radiographic X-Ray System (K904146) received a 510(k) decision of Substantially Equivalent on December 13, 1990, 97 days after the submission was received.
What is the product code of K904146?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.