510(k) · Cleared
ClearedPacs Scan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacsgear, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 28, 2009 as substantially equivalent to K982862 (Applicare Medical Imaging, B.V., 1998) after a 51-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Jan 28, 2009
- Review
- 51 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896095 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 2 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 1 generation backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- This deviceK083618 Pacs ScanPacsgear, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK131392 Etiam Pacs ComponentsEtiam S.A.S.U. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131392Etiam Pacs ComponentsEtiam S.A.S.U. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −2 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −1 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| 0 (this device) | K083618 | Pacs Scan | Pacsgear, Inc. | 2009 | — |
| +1 | K131392 | Etiam Pacs Components | Etiam S.A.S.U. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K982862 | Radworks Medical Imaging Software with Quality Control ModuleSummary page 1…e: LLZ Predicate Device Information: Device Name: RadWorks Medical Imaging Software with Quality Control Module Manufacturer: Applicare Medical Imaging, B.V. Reference: K982862 Device Description: The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform v… | 1998 |
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 |
|---|---|---|---|
| K131392 | Etiam Pacs Components | 2013 | 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 19 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131392 (Etiam S.A.S.U., 2013) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K982862.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083618 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083618: Pacs Scan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083618
Report an extraction error
Are you the manufacturer?
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