510(k) · Cleared
ClearedEFAI PACS Picture Archiving and Communication System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ever Fortune.Ai, Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Sep 10, 2021 as substantially equivalent to K171544 (Arterys, Inc., 2017) after a 137-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Sep 10, 2021
- Review
- 137 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K922164 (1993). 9 ancestors in all, the oldest K920319 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 4 generations backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- 3 generations backK043146 Horizon Medical ImagingMckesson Medical Imaging Company · 2005 · Recalled
- 2 generations backK152186 HealthMyne PACSHealthmyne, Inc. · 2015
- 1 generation backK171544 Arterys ViewerArterys, Inc. · 2017
- This deviceK211257 EFAI PACS Picture Archiving and Communication SystemEver Fortune.Ai, Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK232100 Efai Pacs Picture Archiving and Communication System ProEver Fortune.Ai, Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232100Efai Pacs Picture Archiving and Communication System ProEver Fortune.Ai, Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −4 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| −3 | K043146 | Horizon Medical Imaging | Mckesson Medical Imaging Company | 2005 | 11 |
| −2 | K152186 | HealthMyne PACS | Healthmyne, Inc. | 2015 | — |
| −1 | K171544 | Arterys Viewer | Arterys, Inc. | 2017 | — |
| 0 (this device) | K211257 | EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai, Co., Ltd. | 2021 | — |
| +1 | K232100 | Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K171544 | Arterys ViewerSummary page 5…Class II Product Code: LLZ 5.3 Equivalence Claimed to Predicate Device The EFAI PACS is equivalent to the Arterys Viewer (K171544), manufactured by Arterys Inc. is provided as primary predicate device. 5.4 Indication for Use EFAI PACS Picture Archiving and… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | 2023 | 0 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K232100 (Ever Fortune.Ai, Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171544.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images…
Read the full statement (144 words)
EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.
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/K211257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211257: EFAI PACS Picture Archiving and Communication System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211257
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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