510(k) · Cleared
ClearedExam Vue PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jpi Healthcare Solutions, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 17, 2017 as substantially equivalent to K092081 (Vieworks Co., Ltd., 2009) and 1 other predicate after a 155-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Mar 17, 2017
- Review
- 155 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930527 (1993). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK930527 Dental LinkEscan, Inc. · 1993
- 2 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 1 generation backK061035 Tigerview ProfessionalTelevere Systems · 2006
- This deviceK162868 Exam Vue PACSJpi Healthcare Solutions, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK213520 Axir-CXRadisen Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213520Axir-CXRadisen Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −2 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −1 | K061035 | Tigerview Professional | Televere Systems | 2006 | — |
| 0 (this device) | K162868 | Exam Vue PACS | Jpi Healthcare Solutions, Inc. | 2017 | — |
| +1 | K213520 | Axir-CX | Radisen Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (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 |
|---|---|---|---|
| * | K092081 | QxlinkSummary page 4…rade/Proprietary Name: ExamVue PACS 3. Predicate Device Manufacturer: Vieworks Co, Ltd Device: QXLink 510(k) Number: K092081 Classification Name: Imaging Processing System, Radiological Common Name: Picture Archiving and Commu… | 2009 |
| * | K061035 | Tigerview ProfessionalSummary page 4…ry Class: II Product Code: 90 LLZ Manufacturer: Televere Device: Tigerview Professional 510(k) Number: K061035 Classification Name: Imaging Processing System, Radiological Common Name: Picture Archiving and Commu… | 2006 |
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 |
|---|---|---|---|
| K213520 | Axir-CX | 2022 | 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 24 years and passes through 4 companies; a new generation was cleared every 10.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K213520 (Radisen Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
ExamVue PACS is an image management system intended to be used by trained professionals, including physicians,
radiologists, nurses and medical technicians.
The software is a software package used with general purpose computing hardware to receive, store, distribute, process
and display images and associated data throughout a clinical environment. The software performs digital image
processing, measurement, communication and storage. This device is not indicated for use in mammography.
ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following
modality types via DICOM: CR and DX.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162868: Exam Vue PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162868
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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