510(k) · Cleared
ClearedCharruapacs System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Charruasoft SA · LLZ System, Image Processing, Radiological
Cleared on Nov 25, 2013 as substantially equivalent to K080334 (Medsphere Technologies Pvt, Ltd., 2008) after a 25-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 25, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945188 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 5 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 4 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 3 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 2 generations backK062490 Visage Pacs/CS, Release Version 4.1Mercury Computer Systems, Inc. · 2006
- 1 generation backK080334 InstaradMedsphere Technologies Pvt, Ltd. · 2008
- This deviceK133357 Charruapacs SystemCharruasoft SA · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −5 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −4 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −3 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −2 | K062490 | Visage Pacs/CS, Release Version 4.1 | Mercury Computer Systems, Inc. | 2006 | — |
| −1 | K080334 | Instarad | Medsphere Technologies Pvt, Ltd. | 2008 | — |
| 0 (this device) | K133357 | Charruapacs System | Charruasoft SA | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K080334 | InstaradSummary page 3…ew device are compared below: InstaRad Feature/Functions - CharruaPACS K080334 If different, Impact on Safety and or DeiePredicate… | 2008 |
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 18 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K080334.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
CharruaPACS System™ is a software based device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways, etc.). Images and data can be captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133357: Charruapacs System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133357
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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