Unity Network Is Patient Viewer
FDA 510(k) K032346 · Ge Medical Systems Information Technologies
510(k) numberK032346
Submission
- Device name
- Unity Network Is Patient Viewer
- Applicant
- Ge Medical Systems Information Technologies
Milwaukee, WI, US - Received
- July 30, 2003
- Decision date
- August 5, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/24/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | 01/26/2026SE |
| K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | 07/09/2025SE |
| K243540 | Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client…DQK · Special | 12/12/2024SE |
| K233810 | Portrait VSMMWI · Traditional | 04/25/2024SE |
| K234130 | Portrait Mobile Monitoring Solution consists of: Portrait Central Viewer Application…MWI · Traditional | 03/20/2024SE |
| K231870 | CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing SystemDQK · Traditional | 12/13/2023SE |
| K230626 | Portrait Central Viewer Application (Portrait CV A01), Portrait Core Services…MWI · Traditional | 08/11/2023SE |
| K230145 | One-CufDXQ · Traditional | 03/14/2023SE |
| K222586 | Mural Clinical ViewerMHX · Traditional | 12/21/2022SE |
Questions and answers
When was Unity Network Is Patient Viewer cleared by the FDA?
Unity Network Is Patient Viewer (K032346) received a 510(k) decision of Substantially Equivalent on August 5, 2003, 6 days after the submission was received.
What is the product code of K032346?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.