510(k) · Cleared
ClearedRaytel Digital Imaging Systems
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 Jan 21, 1993 after a 258-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 390 devices in its family, counting itself, has a Class I recall. 389 later devices descend from it.
- Decided
- Jan 21, 1993
- Review
- 258 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 0
389 later devices descend from it, 4 citing it directly. 1 of the 390 devices in this family, counting this one, has a Class I recall.
- This deviceK922164 Raytel Digital Imaging SystemsOlicon Imaging Systems, Inc. · 1993
- Descendant · cites it directly · 380 of its ownK973959 Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997
- Descendant · 2 generations on · 354 of its ownK981535 Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999
- Descendant · 3 generations on · 353 of its ownK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- Descendant · 4 generations on · 350 of its ownK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- Descendant · 5 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
Showing 5 of 389 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…11 generations on · 2025
Most influential descendants
Showing 5 of 389 · See all- K973959Olicon Imaging Systems, Inc. 02-Workstation and/or Pacsview SoftwareOlicon Imaging Systems, Inc. · 1997 · cites it directly380descendants
- K981535Focus Pilot Contouring WorkstationComputerized Medical Systems, Inc. · 1999 · 2 generations on354descendants
- K052379Mim 3.5 (Circa)Mimvista Corp. · 2005 · 3 generations on353descendants
- K060816Mim 4.0 (NeuroMimvista Corp. · 2006 · 4 generations on350descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 5 generations on287descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K981535 | Focus Pilot Contouring Workstation | Computerized Medical Systems, Inc. | 1999 | — |
| +3 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| +4 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| +5 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 8 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 13 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 18 | 0 |
| 2018 | 25 | 0 |
| 2019 | 25 | 0 |
| 2020 | 28 | 0 |
| 2021 | 26 | 0 |
| 2022 | 32 | 0 |
| 2023 | 31 | 0 |
| 2024 | 29 | 0 |
| 2025 | 39 | 1 |
| 2026 | 36 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (389)
See all 3894 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K973959 (Olicon Imaging Systems, Inc., 1997) has gone furthest, with 380 descendants of its own.
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 | — |
https://510kreport.com/device/K922164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922164: Raytel Digital Imaging Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922164
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026