Radiforce Large Monitor System
FDA 510(k) K112645 · Eizo GmbH
510(k) numberK112645
Submission
- Device name
- Radiforce Large Monitor System
- Applicant
- Eizo GmbH
Karlsrube, DE - Received
- September 12, 2011
- Decision date
- September 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
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|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K262397 | CuratOR EX2742GCJ · Traditional | 09/11/2026SE |
| K262783 | RadiForce MX247WPGY · Abbreviated | 09/01/2026SE |
| K252030 | RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated | 08/28/2025SE |
| K242545 | RadiForce MX317W-PAPZZ · Abbreviated | 05/23/2025SE |
| K243221 | RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated | 11/27/2024SE |
| K241441 | RadiForce RX670; RadiForce RX670-ARPGY · Abbreviated | 07/16/2024SE |
| K233465 | RadiForce MX317WPGY · Abbreviated | 12/21/2023SE |
| K231066 | CuratOR EX3242-FDGCJ · Traditional | 12/18/2023SE |
| K230684 | RadiForce MX217PGY · Abbreviated | 05/12/2023SE |
| K223768 | RadiForce RX270PGY · Abbreviated | 04/20/2023SE |
Questions and answers
When was Radiforce Large Monitor System cleared by the FDA?
Radiforce Large Monitor System (K112645) received a 510(k) decision of Substantially Equivalent on September 22, 2011, 10 days after the submission was received.
What is the product code of K112645?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.