510(k) Report

510(k) · Cleared

Cleared

Surgicad (TM) View (TM)

K924630510(k) TraditionalCleared Apr 7, 1993205-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Surgicad Corp. · LLZ System, Image Processing, Radiological

Cleared on Apr 7, 1993 after a 205-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 382 later devices descend from it.

Decided
Apr 7, 1993
Review
205 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

382 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2004: 2 descendants cleared2012: 12 descendants cleared2007: 4 descendants cleared2011: 9 descendants cleared2006: 6 descendants cleared2014: 13 descendants cleared2005: 3 descendants cleared2008: 3 descendants cleared2009: 3 descendants cleared2022: 26 descendants cleared2020: 29 descendants cleared2018: 20 descendants cleared2013: 16 descendants cleared2016: 17 descendants cleared2010: 2 descendants cleared2017: 22 descendants cleared2019: 23 descendants cleared2015: 12 descendants cleared2021: 24 descendants cleared2023: 43 descendants cleared2024: 25 descendants cleared2025: 33 descendants cleared2026: 33 descendants cleared1990200020102020
  1. This deviceK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
  2. Descendant · cites it directly · 380 of its ownK970617 CT-Modeller SystemMaterialise NV · 1997
  3. Descendant · 2 generations on · 379 of its ownK033849 Simplant SystemMaterialise NV · 2004
  4. Descendant · 3 generations on · 143 of its ownK073449 SurgicaseMaterialise NV · 2008
  5. Descendant · 3 generations on · 141 of its ownK073468 MimicsMaterialise NV · 2008
  6. Descendant · 4 generations on · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled

Showing 5 of 382 descendants. See all descendants

Descendants cleared per year

1997: 22004: 22005: 32006: 62007: 42008: 32009: 32010: 22011: 92012: 122013: 162014: 132015: 122016: 172017: 222018: 202019: 232020: 292021: 242022: 262023: 432024: 252025: 332026: 33
1997high 43 (2023) · low 0 (1998)2026

Most influential descendants

Showing 5 of 382 · See all
  • K970617CT-Modeller SystemMaterialise NV · 1997 · cites it directly380descendants
  • K033849Simplant SystemMaterialise NV · 2004 · 2 generations on379descendants
  • K073449SurgicaseMaterialise NV · 2008 · 3 generations on143descendants
  • K073468MimicsMaterialise NV · 2008 · 3 generations on141descendants
  • K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · 4 generations on99descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924630Surgicad (TM) View (TM)Surgicad Corp.1993—
+1K970617CT-Modeller SystemMaterialise NV1997—
+2K033849Simplant SystemMaterialise NV2004—
+3K073449SurgicaseMaterialise NV2008—
+3K073468MimicsMaterialise NV2008—
+4K102795Signature Planner; Signature GuidesMaterialise NV20114

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
200420
200530
200660
200740
200830
200930
201020
201190
2012120
2013160
2014130
2015120
2016170
2017220
2018200
2019230
2020290
2021240
2022260
2023430
2024250
2025330
2026330
FIG. 1 — Lineage of K924630, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (382)

See all 382

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970617CT-Modeller SystemMaterialise NV1997380
K971290Stratasys FDM Medmodeler SystemPaladin Medical, Inc.19970

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?

  • Of its descendants, K970617 (Materialise NV, 1997) has gone furthest, with 380 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

Recent decisions in LLZ

The LLZ category page

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https://510kreport.com/device/K924630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924630: Surgicad (TM) View (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924630

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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