← Product Code [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI) · K955059 # OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER (K955059) _Siemens Medical Solutions USA, Inc. · DSI · Jun 7, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K955059 ## Device Facts - **Applicant:** Siemens Medical Solutions USA, Inc. - **Product Code:** [DSI](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI.md) - **Decision Date:** Jun 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1025 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Indications for Use Olympus Communications Network: To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers. SC 3000 Workstation: To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network. SC 3000 Remote Display: To act as a Slave Display for the SC 3000 Workstation. ## Device Story System comprises Olympus Communications Network, SC 3000 Workstation, and SC 3000 Remote Display. Network facilitates data communication between patient monitors (SC 9000/9015, SC 6000/6000P), recorders, and printers. SC 3000 Workstation functions as central monitoring hub, aggregating patient data from connected monitors for clinician review. SC 3000 Remote Display acts as slave unit for workstation. Used in clinical settings by healthcare professionals to monitor patient physiological data. System enables centralized oversight of patient status, supporting clinical decision-making through real-time data display and alarm management. ## Clinical Evidence Bench testing only. No clinical data provided. Safety and effectiveness demonstrated through compliance with electrical safety standards (IEC 601-1, UL 544, UL 433, UL 1950, EN 60950, CSA 22.2 No. 950) and internal qualification testing against product specifications. ## Technological Characteristics Networked patient monitoring system. Components include communications network, central workstation, and remote display. Electrical safety compliance: IEC 601-1, UL 544, UL 433, UL 1950, EN 60950, CSA 22.2 No. 950. Connectivity: Networked system for data transmission between monitors, recorders, and printers. CE marked. ## Regulatory Identification The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. ## Special Controls *Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document. ## Predicate Devices - SIRENET Communications Network ([K920445](/device/K920445.md)) - Unity Network ([K900598](/device/K900598.md), [K901072](/device/K901072.md), [K912799](/device/K912799.md)) - SIRECUST 120/121C Central Station ([K920445](/device/K920445.md)) - SIRECUST 120/121S Slave Display ([K920445](/device/K920445.md)) - CentralScope 12 Central Station ([K901072](/device/K901072.md)) - Remote Color Display ([K901884](/device/K901884.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) Notification: Siemens Olympus Communications Network, SC 3000 Workstation and Remote Display # SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A DETERMINATION OF SUBSTANTIAL EQUIVALENCE ## I. GENERAL INFORMATION **K955059** **JUN - 7 1996** **Class II:** 21 CFR 870.2300 Cardiac monitor (Cardiotachometer and Rate Alarm). 21 CFR 870.2450 Medical Cathode-Ray Tube Display **Class III:** 21 CFR 870.1025 Arrhythmia detector and alarm. **Common Names:** **Olympus Communications Network** Communications Network, Patient Monitoring Network, Information Network; **SC 3000 Workstation** Central Station Monitor, Central Nursing Station; **SC 3000 Remote Display** Slave Display, Repeater Display; **Device Trade Names:** Siemens Olympus Communications Network SC 3000 Workstation SC 3000 Remote Display **Intended Uses:** **Olympus Communications Network** To act as a communications network for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems, the SC 3000 Workstation, R 50 (K944350) and R 100 Recorders, and laser printers. **SC 3000 Workstation** To act as a central monitoring device for the SC 9000/9015 (K946306) and SC 6000/6000P (K944350) Patient Monitoring Systems through its connection to the Siemens Olympus Communications Network. **SC 3000 Remote Display** To act as a Slave Display for the SC 3000 Workstation. **Establishment Name and Address:** Siemens Medical Electronics, Inc. 16 Electronics Avenue Danvers, MA 01923 **Establishment registration Number:** 1220063 **Performance Standard:** None established under Section 514 or Section 358 SIEMENS MEDICAL SYSTEMS. INC CONFIDENTIAL March 21, 1996 Pg. 1 {1} 510(k) Notification: Siemens Olympus Communications Network, SC 3000 Workstation and Remote Display ## II. SAFETY AND EFFECTIVENESS INFORMATION ### ELECTRICAL: **Compliance with Standards:** Olympus Communication and Power Supply (CPS): IEC 601-1, UL 544 SC 3000 Workstation Unit: UL 433, EN 60950, CE Mark SC 3000 Remote Display: UL 1950, CSA 22.2 No. 950, EN 60950, CE Mark ### OPERATION: The device labeling contains instructions for use which assures safe and effective use of the devices. ### DEVELOPMENT: Medical device development is conducted in accordance with an approved Siemens Product Planning Process and Engineering Process. Product specifications, hazards analysis, software development plan and device test plan are required parts of the device development process. Qualification test results which demonstrate that the device performs in accordance with its specification are required before product release. SIEMENS MEDICAL SYSTEMS. INC CONFIDENTIAL March 21, 1996 Pg. 2 {2} 510(k) Notification: Siemens Olympus Communications Network, SC 3000 Workstation and Remote Display ## III. SUBSTANTIAL EQUIVALENCE The devices listed below have the same intended uses and technological characteristics: | Siemens' New Device | Equivalent Device (Siemens) | K # | Equivalent Device (Marquette) | K # | | --- | --- | --- | --- | --- | | Olympus Communications Network | SIRENET Communications Network | K920445 | Unity Network | applicable to: K900598 K901072 K912799 | | SC 3000 Workstation and Remote Display | SIRECUST 120/121C Central Station SIRECUST 120/121S Slave Display | K920445 K920445 | CentralScope™ 12 Central Station Remote Color Display | K901072 K901884 | SIEMENS MEDICAL SYSTEMS. INC CONFIDENTIAL March 21, 1996 Pg. 3 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K955059](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSI/K955059) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com