510(k) · Cleared
ClearedSpinal Guides Pacs (Pacs Medical Imaging Display Workstation)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Albert Davydov Dds PC Professional · LLZ System, Image Processing, Radiological
Cleared on Mar 16, 2010 as substantially equivalent to K063337 (Viztek, Inc., 2006) after a 221-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Mar 16, 2010
- Review
- 221 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010259 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK010259 Mediface PacsMediface Co., Ltd. · 2001
- 3 generations backK012844 Marosis PacsMarotech, Inc. · 2001
- 2 generations backK032176 Rattan Imacs by Rattan Information CorporationRattan Information Corporation · 2003
- 1 generation backK063337 Opal-RadViztek, Inc. · 2006
- This deviceK092427 Spinal Guides Pacs (Pacs Medical Imaging Display Workstation)Albert Davydov Dds PC Professional · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010259 | Mediface Pacs | Mediface Co., Ltd. | 2001 | — |
| −3 | K012844 | Marosis Pacs | Marotech, Inc. | 2001 | — |
| −2 | K032176 | Rattan Imacs by Rattan Information Corporation | Rattan Information Corporation | 2003 | — |
| −1 | K063337 | Opal-Rad | Viztek, Inc. | 2006 | — |
| 0 (this device) | K092427 | Spinal Guides Pacs (Pacs Medical Imaging Display Workstation) | Albert Davydov Dds PC Professional | 2010 | — |
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 |
|---|---|---|---|
| * | K063337 | Opal-RadSummary page 1…6491 Powers Ave. Jacksonville, FL 32217 510(K) Number K063337 Regulation # 21 CFR 892.2050 1 of I… | 2006 |
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 9 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K063337.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Spinal Guides PACS is intended to perform: operations relating to the acceptance of spinal X-ray medical images and patient demographic information, their display, digital processing, review and editing, measurements report generation with respective storage and teleradiology exchange capabilities.
They are intended to be used by a physician to view the images and use as an aid in calculation of alteration of motion segment integrity (AOMSI) of human spine.
This device is not intended to be used for mammography images and does not require usage of 5 Mega pixel monitors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092427: Spinal Guides Pacs (Pacs Medical Imaging Display Workstation).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092427
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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