510(k) · Cleared
ClearedAurora
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Israel, Functional Imaging · KPS System, Tomography, Computed, Emission
Cleared on Jan 17, 2025 as substantially equivalent to K093514 (Ge Medical Systems F.I. Haifa, 2009) after a 57-day review. Its family tree reaches back 8 generations to 1995. 5 of the 33 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 17, 2025
- Review
- 57 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K952674 (1995). 31 ancestors in all, the oldest K892358 (1989). 1 later device descends from it, 1 citing it directly. 5 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 7 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 6 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 5 generations backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
- 4 generations backK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
- 3 generations backK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
- 2 generations backK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 1 generation backK093514 Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Recalled (Class I)
- This deviceK243605 AuroraGe Medical Systems Israel, Functional Imaging · 2025
- Descendant · cites it directly · 0 of its ownK251153 AuroraGe Medical Systems Israel · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251153AuroraGe Medical Systems Israel · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −7 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −6 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −5 | K023190 | E.Cam Computer / E.Soft Workstation | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −4 | K063826 | Syngo MI Applications 2007A | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −3 | K072567 | Symbia-E, Model 10275879 | Siemens Medical Solutions USA, Inc. | 2007 | 2 |
| −2 | K082506 | Symbia, Version 4.0 | Siemens Medical Solutions USA, Inc. | 2008 | 9 |
| −1 | K093514 | Discovery Model NM/CT 670 | Ge Medical Systems F.I. Haifa | 2009 | Class I |
| 0 (this device) | K243605 | Aurora | Ge Medical Systems Israel, Functional Imaging | 2025 | — |
| +1 | K251153 | Aurora | Ge Medical Systems Israel | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 1 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 1 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 1 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
5 devices in this family have 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.7 · 17 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 |
|---|---|---|---|
| * | K093514 | Discovery Model NM/CT 670Summary page 7…vice Information Device Name Discovery NM/CT 670 Manufacturer GE Medical Systems Israel, Functional Imaging 510(k) number K093514 Regulation number 21CFR 892.1200 and 21CFR 892.1750 Product Code KPS and JAK… | 2009 |
| † | K213938 | Revolution Ascend | 2022 |
| † | K173816 | NM/CT 850, NM/CT 860 | 2018 |
| † | K221680 | Xeleris V Processing and Review System | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251153 | Aurora | 2025 | 0 |
Has anything in its family been recalled? (5 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.
- K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K052434Hawkeye 4 Option for Dual-Head Variable Angle Gamma CameraGE Medical Systems · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 11 Class I recall
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 21 of the 31 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K251153 (Ge Medical Systems Israel, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K093514.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning…
Read the full statement (327 words)
The Aurora system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in the assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors; and planning, guiding, and monitoring therapy, including the nuclear medicine part of theragnostic procedures.
• NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT), Imaging modes include single photon, multi-isotope, and multi-peak, with data stored in frame/list mode. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring.
• CT System: produces Cross sectional images of the body by computer reconstruction of X-Ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained with or without contrast. The CT system is indicated for head, whole body, cardiac and vascular X-Ray Computed Tomography applications.
• NM+ CT System: Combined, hybrid SPECT and CT protocols, for CT-based SPECT attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration, and fusion).
The Aurora system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may include digital processing of data and images, including display, quality check, transfer, and processing, to produce images in a variety of trans-axial and reformatted planes. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation. The system may be used for patients of all ages.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243605: Aurora.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243605
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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