510(k) · Cleared
ClearedZenis, Picture Archiving and Communications System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoray Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Aug 26, 2011 as substantially equivalent to K042525 (Ge Medical Systems Information Technologies, 2004) after a 302-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Aug 26, 2011
- Review
- 302 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 deviceK103181 Zenis, Picture Archiving and Communications SystemGenoray Co., Ltd. · 2011
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) | K103181 | Zenis, Picture Archiving and Communications System | Genoray Co., Ltd. | 2011 | — |
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 Information Technologies Device Name: RA600 5 10(k) Number: K042525 (Decision Date - October 1, 2004) Classification: System, Image Processing, Radiological: LLZ,… | 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 27 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. 2011, 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?
Zenis is intended for viewing of images acquired from Fluoroscopic X-ray system when installed on suitable commercial-standard PC hardware. Zenis is intended for use as a primary diagnostic and analysis workstation in Radiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and. may be part of a larger PACS configuration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103181: Zenis, Picture Archiving and Communications System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103181
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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