510(k) · Cleared
ClearedIntegrated Registration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · LLZ System, Image Processing, Radiological
Cleared on Oct 30, 2009 as substantially equivalent to K010336 (Ge Medical Systems, Inc., 2001) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Oct 30, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K941223 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK941223 Advance Analysis SoftwareGeneral Electric Co. · 1994
- 2 generations backK983256 Advantage Windows (AW) FusionGE Medical Systems · 1998
- 1 generation backK022310 Advantage Windows X-Ray/MR FusionGe Medical Systems, Inc. · 2002
- This deviceK093234 Integrated RegistrationGE Medical Systems SCS · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941223 | Advance Analysis Software | General Electric Co. | 1994 | — |
| −2 | K983256 | Advantage Windows (AW) Fusion | GE Medical Systems | 1998 | — |
| −1 | K022310 | Advantage Windows X-Ray/MR Fusion | Ge Medical Systems, Inc. | 2002 | — |
| 0 (this device) | K093234 | Integrated Registration | GE Medical Systems SCS | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K010336 | Advantage Windows CT/Pet Fusion | 2001 |
| * | K983256 | Advantage Windows (AW) FusionSummary page 1…Product Code: 9OLLZ Predicate Devices: K01,0336: Advantage Windows CT/PET Fusion K983256: Advantage Windows (CT/MR) Fusion K0223 10: Advantage Windows X-Ray/MR Fusion De… | 1998 |
| * | K022310 | Advantage Windows X-Ray/MR FusionSummary page 1…K01,0336: Advantage Windows CT/PET Fusion K983256: Advantage Windows (CT/MR) Fusion K0223 10: Advantage Windows X-Ray/MR Fusion Device Description: The INTEGRATED REGISTRATION tool runs on Advantage… | 2002 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 8 other devices also cite its predicate K010336.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
INTEGRATED REGISTRATION provides easy means for comparison of three-dimensional (3D) images from Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Emission Tomography (PET or SPECT) and X-Ray Angiography (XA). To help physicians in diagnostic radiology or therapy planning, INTEGRATED REGISTRATION allows 3D registration between volumetric acquisitions that may come from the same acquisition modality or from different acquisition modalities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093234: Integrated Registration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093234
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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