510(k) · Cleared
ClearedCsist Dicom Gateway/Image Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Csist · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2001 as substantially equivalent to K973959 (Olicon Imaging Systems, Inc., 1997) and 1 other predicate after a 150-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Dec 20, 2001
- Review
- 150 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922164 (1993). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 1 generation backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- This deviceK012327 Csist Dicom Gateway/Image ManagerCsist · 2001
- Descendant · cites it directly · 0 of its ownK092581 Mits Dicom Gateway and Image ManagerMitsmed Medical Instrument Technology Co., Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K092581Mits Dicom Gateway and Image ManagerMitsmed Medical Instrument Technology Co., Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −1 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| 0 (this device) | K012327 | Csist Dicom Gateway/Image Manager | Csist | 2001 | — |
| +1 | K092581 | Mits Dicom Gateway and Image Manager | Mitsmed Medical Instrument Technology Co., Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareSummary page 1…ufacturer OLICON Imaging Systems, Inc. A.L.l. Technologies, Inc Device Name OLICON 02 Workstation & PACS | ALl 3D Tool Module for View Software Medical Images K Number K973959 K003762 Decision Date 12/22/97 2/28/01 Product Code 90 LMD 90 LLZ Classification Class 1l Class lI Device Description: 21 CFR… | 1997 |
| * | K003762 | Ali 3D Tool Module for Medical ImagesSummary page 1…r OLICON Imaging Systems, Inc. A.L.l. Technologies, Inc Device Name OLICON 02 Workstation & PACS | ALl 3D Tool Module for View Software Medical Images K Number K973959 K003762 Decision Date 12/22/97 2/28/01 Product Code 90 LMD 90 LLZ Classification Class 1l Class lI Device Description: 21 CFR 807 92(… | 2001 |
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 |
|---|---|---|---|
| K092581 | Mits Dicom Gateway and Image Manager | 2009 | 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 8 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092581 (Mitsmed Medical Instrument Technology Co., Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K973959.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 CSIST DICOM Gateway and Image Manager™ is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources (i.e. ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to
physicians, nurses, and technicians.
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/K012327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012327: Csist Dicom Gateway/Image Manager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012327
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026