510(k) · Cleared
ClearedOrthopedic Software for Impax Workstations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corp. · LLZ System, Image Processing, Radiological
Cleared on Jul 30, 2007 as substantially equivalent to K050751 (Agfa Corp., 2005) and 1 other predicate after a 13-day review. Its family tree reaches back 4 generations to 1991. 133 later devices descend from it.
- Decided
- Jul 30, 2007
- Review
- 13 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904519 (1991). 10 ancestors in all. 133 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 3 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 2 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 1 generation backK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- This deviceK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- Descendant · cites it directly · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · 2 generations on · 51 of its ownK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · 2 generations on · 28 of its ownK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- Descendant · 2 generations on · 27 of its ownK141669 SurgimapNemaris, Inc. · 2014
- Descendant · 2 generations on · 21 of its ownK160284 JointPointJointpoint, Inc. · 2016
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 133 · See all- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · cites it directly117descendants
- K111019Surgimap (TM) SpineNemaris, Inc. · 2011 · 2 generations on51descendants
- K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015 · 2 generations on28descendants
- K141669SurgimapNemaris, Inc. · 2014 · 2 generations on27descendants
- K160284JointPointJointpoint, Inc. · 2016 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −3 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −2 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −1 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| 0 (this device) | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| +1 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +2 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +2 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| +2 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
| +2 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 11 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 24 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K050751 | Impax Orthopaedic Workstation, Model Impax ES 5.XSummary page 2…PREDICATE DEVICES This is a 510(k) for Agfa's Orthopedic Software for Impax Workstations. The predicate devices are Agfa's previous orthopedic workstation, the OT-3000 (K050751) and Cedara Software Corporation's I-SoftView Orthopedic Tools Set (K022881). The new device is nearly identical to Agfa's previo… | 2005 |
| * | K022881 | Cedara I-SoftviewSummary page 2…Workstations. The predicate devices are Agfa's previous orthopedic workstation, the OT-3000 (K050751) and Cedara Software Corporation's I-SoftView Orthopedic Tools Set (K022881). The new device is nearly identical to Agfa's previous version, except for the addition of a spine-planning module. The Cedara p… | 2002 |
What descends from it? (133)
See all 1337 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K073714 (Orthocrat, Ltd., 2008) has gone furthest, with 117 descendants of its own.
- 1 other device also cites its predicate K050751.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information. The software application allows orthopedic…
Read the full statement (152 words)
Agfa's Orthopedic Software is indicated for use with Impax® Workstations in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. It is intended for use by physicians to aid in diagnosis, and by medical professionals whenever they require or desire access to medical images and patient demographic information.
The software application allows orthopedic surgeons and specialists to assess images, plan surgical procedures, monitor patient progress and educate patients in a digital environment.
It allows assessments to be made of geometrical skeletal parameters with comparisons against normative references for adults and children in order to draw therapeutic conclusions. It includes modules for the hip, knee, spine, leg, hand, wrist, elbow, shoulder, foot, ankle and fractures (trauma planning). Users can access a library of manufacturers electronic templates intended to assist in the selection and positioning of implants and the marking of tissues prior to surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071972: Orthopedic Software for Impax Workstations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071972
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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