510(k) · Cleared
ClearedMits Dicom Gateway and Image Manager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitsmed Medical Instrument Technology Co., Ltd. · LLZ System, Image Processing, Radiological
Cleared on Oct 30, 2009 as substantially equivalent to K012327 (Csist, 2001) after a 70-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Oct 30, 2009
- Review
- 70 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922164 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- 2 generations backK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- 1 generation backK012327 Csist Dicom Gateway/Image ManagerCsist · 2001
- This deviceK092581 Mits Dicom Gateway and Image ManagerMitsmed Medical Instrument Technology Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| −2 | K973959 | Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview Software | Olicon Imaging Systems, Inc. | 1997 | — |
| −1 | K012327 | Csist Dicom Gateway/Image Manager | Csist | 2001 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K012327 | Csist Dicom Gateway/Image ManagerSummary page 1…ety and Effectiveness Information * Predicate Device: Claim of Substantial Equivalence (SE) is made to CSIST DICOM Gateway and Image Manager, K012327. * Device Description: MITS DICOM Gateway and Image Manager is a suite of applications designed and produced… | 2001 |
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 16 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
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 MITS 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 System, 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…
Read the full statement (154 words)
The MITS 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 System, 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 medical professionals, including physicians, nurses, technicians and computer system professionals.
To support the diagnostic interpretation of mammography studies the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film Screen images must not be reviewed for primary diagnosis or image interpretation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092581: Mits Dicom Gateway and 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/K092581
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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