510(k) · Cleared
ClearedDCAS I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gp&P Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jul 3, 2014 as substantially equivalent to K042525 (Ge Medical Systems Information Technologies, 2004) after a 91-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Jul 3, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K842308 (1984). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 4 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 3 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 2 generations backK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- 1 generation backK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- This deviceK140869 DCAS IGp&P Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −4 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −3 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −2 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| −1 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| 0 (this device) | K140869 | DCAS I | Gp&P Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Summary page 1…Manufacturer: -:GE Medical Systems In formation Technologies Device: Centricity Cardiology CA1000 510(k) Number: :K042525 (Decision Date - 10/01/2004) 4. Classifications Names &Citations 21CFR 892.2050, LLZ, Picture archiving and communication… | 2004 |
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 30 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 3 other devices also cite its predicate K042525.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The DCAS i allows the user to look up, keep, and manage all the medical images used in cardiology with Anglo, ECHO, and IVUS images as the basic ones. It allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can…
Read the full statement (200 words)
The DCAS i allows the user to look up, keep, and manage all the medical images used in cardiology with Anglo, ECHO, and IVUS images as the basic ones. It allows the user to view, arrange, and manage the needed image by only controlling it in a simple way. Also, as the user can arrange images as he or she wants regardless of the sort of the images, the user can compare and analyze the images of all the equipments of cardiology on this system. The user can record the images of the patient wanted on a CD or DVD. Here, the exclusive viewer allows the user to check the recorded images of the patient in all sorts of environment. In addition, the user can edit and convert the DICOM Cine images into AVM and static images to use them for editing various images and framing a report. Only the user authorized by using the Internet can use this system based on the Web, and in an environment with a wireless network built, the user can look up data through a mobile device.
DCAS i images can be used for reference purposes only and cannot be used for precise readings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140869: DCAS I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140869
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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