510(k) · Cleared
ClearedOlicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, Archive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O Tech, Inc. · LMB Device, Digital Image Storage, Radiological
Cleared on Dec 2, 1997 as substantially equivalent to K922164 (Olicon Imaging Systems, Inc., 1993) after an 81-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.
- Decided
- Dec 2, 1997
- Review
- 81 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922164 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- This deviceK973463 Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE…O Tech, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK992131 Samsung Raypax Long Term ArchiveSamsung Sds Co., Ltd. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992131Samsung Raypax Long Term ArchiveSamsung Sds Co., Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922164 | Raytel Digital Imaging Systems | Olicon Imaging Systems, Inc. | 1993 | — |
| 0 (this device) | K973463 | Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, Archive | O Tech, Inc. | 1997 | — |
| +1 | K992131 | Samsung Raypax Long Term Archive | Samsung Sds Co., Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 LMB? 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 |
|---|---|---|---|
| * | K922164 | Raytel Digital Imaging SystemsSummary page 1…tal Archive Internal Company Names - NT Archive, 02Archive, Archive Predicate Device: OLICON IMAGING SYSTEMS, INC. Device: RAYTEL DIGITAL IMAGING SYSTEMS 510(k) Number: K922164 Date Received: 05/08/92 Decision Date: 01/21/93 Decision: Substantially Equivalent Panel Code device reviewed by:Radiology Panel… | 1993 |
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 |
|---|---|---|---|
| K992131 | Samsung Raypax Long Term Archive | 1999 | 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?
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | — | 0 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olicon Imaging Systems, NT Archive Systems stores and retrieves digital images together with information about the images. The device communicates with other devices via the DICOM standard network protocol.
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/K973463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973463: Olicon Imaging Systems, Inc. Archive Systems, NT Archive, 02ARCHIVE, Archive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973463
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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