510(k) · Cleared
ClearedOrthocad Software Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · LLZ System, Image Processing, Radiological
Cleared on Sep 19, 2012 as substantially equivalent to K111803 (Esaote, S.p.A., 2011) and 1 other predicate after a 232-day review. Its family tree reaches back 13 generations to 1991.
- Decided
- Sep 19, 2012
- Review
- 232 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K911667 (1991). 52 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 9 generations between
- 3 generations backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- 2 generations backK110238 G-SCANEsaote, S.p.A. · 2011
- 1 generation backK111803 G-SCANEsaote, S.p.A. · 2011
- This deviceK120288 Orthocad Software OptionEsaote, S.p.A. · 2012
Show all 13 generations
- Root · 13 generations backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
- 12 generations backK963262 Artoscan MBiosound, Inc. · 1997
- 11 generations backK981358 Artoscan SBiosound Esaote, Inc. · 1998
- 10 generations backK990968 E-SCANBiosound Esaote, Inc. · 1999
- 9 generations backK020164 E-Scan XQBiosound Esaote, Inc. · 2002
- 8 generations backK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
- 7 generations backK042236 G-SCANEsaote, S.p.A. · 2004
- 6 generations backK060956 G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan…Esaote, S.p.A. · 2006
- 5 generations backK061429 Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan OperaEsaote, S.p.A. · 2006
- 4 generations backK080968 S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan…Esaote, S.p.A. · 2008
- 3 generations backK092469 O-Scan MR SystemEsaote, S.p.A. · 2009
- 2 generations backK110238 G-SCANEsaote, S.p.A. · 2011
- 1 generation backK111803 G-SCANEsaote, S.p.A. · 2011
- This deviceK120288 Orthocad Software OptionEsaote, S.p.A. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911667 | Hitachi MRP-7000 Magnetic Rosonance Device | Hitachi Medical Systems America, Inc. | 1991 | 2 |
| −12 | K963262 | Artoscan M | Biosound, Inc. | 1997 | — |
| −11 | K981358 | Artoscan S | Biosound Esaote, Inc. | 1998 | — |
| −10 | K990968 | E-SCAN | Biosound Esaote, Inc. | 1999 | — |
| −9 | K020164 | E-Scan XQ | Biosound Esaote, Inc. | 2002 | — |
| −8 | K032121 | Modification to E-Scan XQ | Esaote, S.p.A. | 2003 | — |
| −7 | K042236 | G-SCAN | Esaote, S.p.A. | 2004 | — |
| −6 | K060956 | G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan… | Esaote, S.p.A. | 2006 | — |
| −5 | K061429 | Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera | Esaote, S.p.A. | 2006 | — |
| −4 | K080968 | S-Scan, G-Scan, Dynamic Mri Software for C-Scan, E-Scanxq & E-Scan Opera | Esaote, S.p.A. | 2008 | — |
| −3 | K092469 | O-Scan MR System | Esaote, S.p.A. | 2009 | — |
| −2 | K110238 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| −1 | K111803 | G-SCAN | Esaote, S.p.A. | 2011 | — |
| 0 (this device) | K120288 | Orthocad Software Option | Esaote, S.p.A. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K111803 | G-SCANSummary page 3…istics The addition of the OrthoCAD Software Option, reflected in this 510(k), does not alter the fundamental scientific technology of the U-scan system, cleared via KI 111803. Performance Data Non-clinical testing of the U-scan system with the addition of the OrthoCAD… | 2011 |
| * | K103475 | Spineanalyer Model SapocSummary page 1…agnetic resonance imaging _________ SpineAnalyzer Spine Analysis 11 LLZ OPTASLA MEDICAL K103475 Software 510(k) SLiitnarydl OthoCA D softwaie option for 0-scani Lsaotc. Sp.A.… | 2011 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 52 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111803.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
OrthoCAD is an option that provides the morphometry of the lumbo-sacral section of the spine, by means of semi-automatic segmentation of MR images, the generation of the relative 3D model and calculation of the significant geometrical properties of the vertebral bodies and spinal canal. When this data is interpreted by a trained physician, it can yield information that may assist diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120288 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120288: Orthocad Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120288
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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