510(k) · Cleared
ClearedMD Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkins Healthcare Technologies · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Jul 2, 2010 as substantially equivalent to K083321 (Curlview Igt, LLC, 2008) and 1 other predicate after a 35-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jul 2, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K941811 (1994). 23 ancestors in all, the oldest K822695 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 3 generations backK992636 HP Carevue 9000 Clinical Information System, Model M2331AHewlett-Packard Co. · 1999 · Recalled
- 2 generations backK073372 Electrophysiology Systems Integrator (Epsi)Systemsone · 2007
- 1 generation backK083321 Cardio-ViewCurlview Igt, LLC · 2008
- This deviceK101474 MD Vision SystemPerkins Healthcare Technologies · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −6 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −5 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −4 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −3 | K992636 | HP Carevue 9000 Clinical Information System, Model M2331A | Hewlett-Packard Co. | 1999 | 8 |
| −2 | K073372 | Electrophysiology Systems Integrator (Epsi) | Systemsone | 2007 | — |
| −1 | K083321 | Cardio-View | Curlview Igt, LLC | 2008 | — |
| 0 (this device) | K101474 | MD Vision System | Perkins Healthcare Technologies | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083321 | Cardio-ViewSummary page 1…fication Panel: Cardiovascular Equivalent Marketed Device(s): 21 CFR 807.92(a)(3) Device 1 510(k) Number: K083321 Regulation Number: 870.2450 Device Name: Cardio-View Applicant:… | 2008 |
| * | K073372 | Electrophysiology Systems Integrator (Epsi)Summary page 1…uct Code: DXJ Device Classification Name: Cardiovascular Monitoring Devices Device 2 510(k) Number: K073 372 Regulation Number: 870.2450 Device Name: SystemsOne, LLC Applicant:… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K083321.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MD VISION System is a video integration system that takes the original source image from one or more devices and sends it out to a variety of locations. * It integrates images from as many as twelve individual video sources (e.g., VGA, DVI, Coaxial, S-video, etc.) * It processes these video inputs (e.g., by size, position, location) * It displays up to 12 images on a Flat Panel LCD display a A touchscreen pad controls the LCD display a It has no…
Read the full statement (140 words)
The MD VISION System is a video integration system that takes the original source image from one or more devices and sends it out to a variety of locations.
* It integrates images from as many as twelve individual video sources (e.g., VGA, DVI, Coaxial, S-video, etc.)
* It processes these video inputs (e.g., by size, position, location)
* It displays up to 12 images on a Flat Panel LCD display
a A touchscreen pad controls the LCD display
a It has no patient applied padts
Typical users are:
• The procedure suite clinicians who need information from several sources on screen instantly showing the visual information in the way they want to see it on a large LCID display that facilitates viewing.
* Users who want to show medical procedures in real time or record medical procedures for teaching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101474 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101474: MD Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101474
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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