# K962811: Spacelabs Medical Multi-Disclosure Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Jun 24, 1997 after 341 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K840932 (1984). 2 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905788: Model M1251A Mon. Full Disclosure Review System, Hewlett-Packard Co. (1991) Summary page 1.
- K840932: Muse-DP, Marquette Electronics, Inc. (1984) Summary page 1.

## Most influential descendants
- K073372: Electrophysiology Systems Integrator (Epsi) (2007), 10 descendants of its own
- K083321: Cardio-View (2008), 9 descendants of its own
- K111320: Globalcardio (2011), 3 descendants of its own
- K122632: Guava II (2014), 2 descendants of its own
- K112645: Radiforce Large Monitor System (2011), 2 descendants of its own

## Indications for use
Data Access - Provides the user with the means to collect multiple patient data directly from a hardwired or telemetry Patient Care Management System (PCMS) monitoring network. Data Storage - Allows the user to retain up to 48 patient waveforms for up to 48 hours. Data Display - Allows the user to pull data from storage or during continuous monitoring by patient and parameter. Data Editing - Provides the user with the means to edit 12-lead ECG waveform data and interpretation text from Spacelabs Medical 12-lead modules connected to the Patient Care Management System (PCMS) monitoring network. Data Printing - Allows the user to print time annotated waveforms and patient data on paper for review or archive history.

Source page: https://510kreport.com/device/K962811
Methodology: https://510kreport.com/methodology