510(k) · Cleared
ClearedHipCheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · QIH Automated Radiological Image Processing Software
Cleared on Sep 29, 2023 as substantially equivalent to K182359 (Stryker Corp., 2018) after a 266-day review. Its family tree reaches back 11 generations to 1994. 1 of the 47 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 29, 2023
- Review
- 266 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K911783 (1994). 46 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations between
- 3 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 2 generations backK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- 1 generation backK182359 HipCheckStryker Corp. · 2018
- This deviceK230045 HipCheckStryker Corp. · 2023
Show all 11 generations
- Root · 11 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 10 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 9 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 8 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 7 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 6 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 5 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 4 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 3 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 2 generations backK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- 1 generation backK182359 HipCheckStryker Corp. · 2018
- This deviceK230045 HipCheckStryker Corp. · 2023
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System6 generations back · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −10 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −9 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −8 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −7 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −6 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −5 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −4 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −3 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −2 | K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip | Stryker Corporation | 2011 | — |
| −1 | K182359 | HipCheck | Stryker Corp. | 2018 | — |
| 0 (this device) | K230045 | HipCheck | Stryker Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 1 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 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.
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.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K182359 | HipCheckSummary page 4…n Name: Picture Archiving and Communications System (21 CFR 892.2050) Regulatory Class: II Product Code: QIH III. PREDICATE DEVICE HipCheck, K182359 This predicate has not been subject to a design-related recall. No reference devices were used in this submissio… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 46 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients. HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist…
Read the full statement (86 words)
HipCheck assists the surgeon to determine quantitative measurements for femoroacetabular impingement (FAI) procedures. HipCheck provides static localization information derived from image processing of intra-operatively acquired static fluoroscopic images, by superposition of virtual measurement tools onto those X-ray images for skeletally mature patients.
HipMap FAI Analysis is a patient-specific report used to support surgeon or radiologist pre-operative clinical decision making. HipMap femoroacetabular impingement (FAI) Analysis provides a morphological analysis of a skeletally mature hip with potential FAI, including measurements and visualizations that describe hip impingement and stability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230045: HipCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230045
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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