510(k) · Cleared
ClearedOlicon Imaging Systems, Inc. Gateway and/or Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olicon Imaging Systems, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on Dec 17, 1997 as substantially equivalent to K963592 (Dejarnette Research Systems, 1996) after a 72-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 17, 1997
- Review
- 72 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963592 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963592 Imageshare Protocol Converting Gateway and/or Software [OS/2 Warp]…Dejarnette Research Systems · 1996
- This deviceK973793 Olicon Imaging Systems, Inc. Gateway and/or SoftwareOlicon Imaging Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963592 | Imageshare Protocol Converting Gateway and/or Software [OS/2 Warp]… | Dejarnette Research Systems | 1996 | — |
| 0 (this device) | K973793 | Olicon Imaging Systems, Inc. Gateway and/or Software | Olicon Imaging Systems, Inc. | 1997 | — |
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 LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K963592 | Imageshare Protocol Converting Gateway and/or Software [OS/2 Warp] 1OOO,[Sun/Solaris] 2000Summary page 1…twork Classification Name: System, Digital Image Communication, accessory Predicate Device: {21 CFR 807.92(a)(3) Applicant: DEJARNETTE RESEARCH SYSTEMS 510(k) Number: K963592 Device: IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE Device Description: [21 CFR 807.92(a)(4)] The Olicon Gateway sys… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources). The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The…
Read the full statement (121 words)
The Olicon Gateway is a uni-directional device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, imaging gateways, or other imaging sources).
The incoming data formats are ACR-NEMA v2.0, DICOM, or SPI (Standard Product Interconnect) or proprietary to the modality source vendor. The Olicon Gateway, converts the imaging or other data into DICOM, ACR-NEMA v2.0, SPI (Standard Product Interconnect) or proprietary data format and transmits the data to one or more user specified locations across a standard general purpose computing network.
Typical users of this system are trained professionals, including but not limited to physicians, nurses and medical 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/K973793 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973793: Olicon Imaging Systems, Inc. Gateway and/or Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973793
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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