510(k) · Cleared
Recalled · 2008Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · MSX System, Network And Communication, Physiological Monitors
Cleared on Aug 11, 2006 after a 28-day review. The FDA summary names no predicate by number. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 11, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- MSX
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK061994 Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 SoftwareGE Healthcare · 2006
- Descendant · cites it directly · 6 of its ownK100133 Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing…Airstrip Technologies, LP · 2010
- Descendant · 2 generations on · 5 of its ownK142106 Decisio Health Patient DashboardDecisio Health, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK213335 Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK241958 WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025
- Descendant · 4 generations on · 0 of its ownK240756 Aitrics-VCAitrics Co., Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K100133Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version 3.1Airstrip Technologies, LP · 2010 · cites it directly6descendants
- K142106Decisio Health Patient DashboardDecisio Health, Inc. · 2015 · 2 generations on5descendants
- K213335Capsule Surveillance SystemCapsule Surveillance Technologies, Sas /Capsule Tech, Inc. · 2022 · 3 generations on3descendants
- K241958WARD-CSS (v1.2.x)Ward 24/7 Aps · 2025 · 4 generations on0descendants
- K240756Aitrics-VCAitrics Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061994 | Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 Software | GE Healthcare | 2006 | — |
| +1 | K100133 | Airstrip Remote Patient Monitoring (RPM) Remote Data Viewing Software, Version… | Airstrip Technologies, LP | 2010 | — |
| +2 | K142106 | Decisio Health Patient Dashboard | Decisio Health, Inc. | 2015 | — |
| +3 | K213335 | Capsule Surveillance System | Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. | 2022 | — |
| +4 | K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025 | — |
| +4 | K240756 | Aitrics-VC | Aitrics Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MSX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSX device
- #1 K242750 Central Stationscore 21.5 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2008 | Not classified | Z-0213-2009 | Software design | Issue 1 -Possible failure of CIC Pro audible alarms: Requests for telemetry defaults from Mobile Care Server could cause excessive CIC Pro memory consumption. This excessive memory consumption may lead to potential loss of audio at the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100133 (Airstrip Technologies, LP, 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
Indication for use for Web Viewer- The Web Viewer displays Information received from other networked devices. It is comprised of a Mobile Care Server and Web Viewer clients. The Mobile CareServer maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Web Vwer clients. The Web Vier client runs on a generic computer that is connected to the hospital local area network (LAN), The Web Viewer can…
Read the full statement (397 words)
Indication for use for Web Viewer- The Web Viewer displays Information received from other networked devices. It is comprised of a Mobile Care Server and Web Viewer clients. The Mobile CareServer maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Web Vwer clients. The Web Vier client runs on a generic computer that is connected to the hospital local area network (LAN), The Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Web Viewe is not a primary alarm source. The device is for use by qualified medical personnel only.
Indication for use for Pocket Viewer. The Pocket Viewer displays information received froe other networked devices. It is cornpised of a Mobile Care Seaver and Pocket Viewer clients. The Mobile Cam Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Pocket Viewer clients. The Pocket Viwver client runs on a generic handheld computer (PDA) that is connected to the hospital local area network (LAN). The Pocket Viewer can be used for viewing or otherwise processing o information from several bedside monitors or ether networked devices. The Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.
Indication for use for Cellular Viewer The Cellular Viewer displays information received from other networked devices. It is crnprised of a Mobile Care Server and Cellular Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohoreda Network or Unity Network and Cellular Viewer clients. The Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network (LAN). The Cellular Viewer can be used fo viewing or otherwise processing of information from several bedside monitors or ether networked devices. The Cellular Viwer can be used for patients in the hospital and it is mearn for consultation and remote monitoring use. The Cellular Viewer is not a primary alarm source. The device is for use by qualified personnel only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061994: Web Viewer, Pocket Viewer and Cellular Viewer with L- WEB05 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061994
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026