510(k) Report

510(k) · Cleared

Cleared

Nexstar Liftoff Pet Application Software Suite

K081426510(k) TraditionalCleared Jun 4, 200814-day reviewClass II21 CFR 892.1200

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

Philips Medical Systems (Cleveland), Inc. · KPS System, Tomography, Computed, Emission

Cleared on Jun 4, 2008 as substantially equivalent to K052640 (Philips Medical Systems (Cleveland), Inc., 2005) after a 14-day review. Its family tree reaches back 9 generations to 1993.

Decided
Jun 4, 2008
Review
14 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K930090 (1993). 22 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 3 other ancestors2001: 3 other ancestors2004: 1 other ancestor2000: 2 other ancestors1997: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestorsK930090 · Helicat · Elscint, Inc. · 1993K961464 · Select/SP · Elscint, Inc. · 1996 · recalledK982060 · Volumax CT Imaging System · Elscint, Inc. · 1998K012009 · MX8000 Idt CT System · Marconi Medical Systems, Inc. · 2001 · recalledK032036 · Gemini 16 · Philips Medical Systems (Cleveland), Inc. · 2003 · recalledK041955 · Gemini Pet/CT Imaging System · Philips Medical Systems (Cleveland), Inc. · 2004 · recalledK042935 · Gemini GXL · Philips Medical Systems (Cleveland), Inc. · 2004 · recalledK051170 · Gemini GXL · Philips Medical Systems (Cleveland), Inc. · 2005 · recalledK052640 · Gemini Raptor · Philips Medical Systems (Cleveland), Inc. · 2005 · recalled19901995200020052010
Other ancestors, by generation 3 generations back: 1 other ancestor4 generations back: 1 other ancestor5 generations back: 2 other ancestors6 generations back: 6 other ancestors7 generations back: 3 other ancestors K052640 · Gemini Raptor · Philips Medical Systems (Cleveland), Inc. · 2005 · recalledK051170 · Gemini GXL · Philips Medical Systems (Cleveland), Inc. · 2005 · recalledK042935 · Gemini GXL · Philips Medical Systems (Cleveland), Inc. · 2004 · recalledK041955 · Gemini Pet/CT Imaging System · Philips Medical Systems (Cleveland), Inc. · 2004 · recalledK032036 · Gemini 16 · Philips Medical Systems (Cleveland), Inc. · 2003 · recalledK012009 · MX8000 Idt CT System · Marconi Medical Systems, Inc. · 2001 · recalledK982060 · Volumax CT Imaging System · Elscint, Inc. · 1998K961464 · Select/SP · Elscint, Inc. · 1996 · recalledK930090 · Helicat · Elscint, Inc. · 1993−50
  1. Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
  2. 5 generations between
  3. 3 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  4. 2 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  5. 1 generation backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  6. This deviceK081426 Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc. · 2008
Show all 9 generations
  1. Root · 9 generations backK930090 HelicatElscint, Inc. · 1993
  2. 8 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
  3. 7 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
  4. 6 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
  5. 5 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
  6. 4 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  7. 3 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  8. 2 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  9. 1 generation backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  10. This deviceK081426 Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K930090HelicatElscint, Inc.1993—
−8K961464Select/SPElscint, Inc.19963
−7K982060Volumax CT Imaging SystemElscint, Inc.1998—
−6K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200161
−5K032036Gemini 16Philips Medical Systems (Cleveland), Inc.20032
−4K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.20042
−3K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.20042
−2K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.200512
−1K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.200536
0 (this device)K081426Nexstar Liftoff Pet Application Software SuitePhilips Medical Systems (Cleveland), Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199510
199710
200020
200130
200330
200410
FIG. 1 — Lineage of K081426, 1993–2008Source: 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), 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 KPS? 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. #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K052640Gemini Raptor
Summary page 1
…90 KPS Classification Panel: Radiology C. Date prepared: April 11, 2008 D. Predicate Device: GEMINI Raptor System (GEMINI TF) (K052640) E. Performance Standards: No performance standards have been developed for process and display applications. F. Intend…
Philips Medical Systems (Cleveland), Inc.200536

Also cleared against K052640: 5 other devices →

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 3 companies; a new generation was cleared every 1.8 years on median.
  • 13 of the 22 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K052640.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KPS

12in 2025

2007: 82008: 172009: 92010: 32011: 72012: 62013: 112014: 112015: 32016: 112017: 112018: 132019: 32020: 122021: 152022: 52023: 122024: 112025: 122026 (partial year): 6
2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007: 38 days median2008: 25 days median2009: 42 days median2010: 91 days median2011: 28 days median2012: 94 days median2013: 84 days median2014: 92 days median2015: 112 days median2016: 65 days median2017: 104 days median2018: 59 days median2019: 60 days median2020: 72 days median2021: 66 days median2022: 60 days median2023: 63 days median2024: 59 days median2025: 65 days median2026 (partial year): 67 days median
2007high 112 (2015) · low 25 (2008)2026

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

Recalls per year · KPS

16in 2025

2007: 222008: 162009: 142010: 42011: 342012: 132013: 132014: 182015: 52016: 162017: 112018: 12, 3 Class I2019: 5, 5 Class I2020: 82021: 42022: 8, 6 Class I2023: 6, 3 Class I2024: 152025: 162026 (partial year): 6
2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007: 382008: 112009: 152010: 442011: 562012: 342013: 2402014: 332015: 242016: 102017: 312018: 262019: 1052020: 222021: 102022: 152023: 222024: 232025: 36
2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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
20078382238
200817251611
20099421415
2010391444
20117283456
20126941334
2013118413240
201411921833
20153112524
201611651610
2017111041131
2018135912 (3)26
20193605 (5)105
20201272822
20211566410
20225608 (6)15
202312636 (3)22
202411591523
202512651636
20266676—

What is it indicated for?

Software contained in the PET Application Suite process, analyze, display, and quantify medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: · The evaluation, detection and diagnosis of lesions, disease and organ function such as cancer, cardiovascular disease…

Read the full statement (161 words)

Software contained in the PET Application Suite process, analyze, display, and quantify medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:

· The evaluation, detection and diagnosis of lesions, disease and organ function such as cancer, cardiovascular disease, and neurological disorders.

· The detection, localization, and staging of tumors and diagnosing cancer patients.

* Treatment planning and interventional radiology procedures.

· The PET Application Suite includes software that provides a quantified analysis of regional cerebral activity from PET images.

Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium

Indications for use as stated in the FDA summary.

Also cleared against K052640

5 other devices cite the same predicate.

  • K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 20173 recalls
  • K140651Celesteion, Pca-9000A/2Toshibamedical Systems Corporation · 20142 recalls
  • K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 20135 recalls
  • K103483Ingenuity TF Pet/MRPhilips Healthcare (Cleveland) · 20114 recalls
  • K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc. · 200813 recalls

More from Philips Medical Systems (Cleveland)…

209 FDA decisions under this applicant name. See the company

  • K171850Philips CT Big BorePhilips Medical Systems (Cleveland), Inc. · 201714 recalls
  • K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc. · 20173 recalls
  • K162838Philips iCT CT SystemPhilips Medical Systems (Cleveland), Inc. · 20176 recalls
  • K163711IQon Spectral CTPhilips Medical Systems (Cleveland), Inc. · 20172 recalls
  • K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc. · 20173 recalls

Recent decisions in KPS

The KPS category page

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia…Siemens Medical Solutions USA, Inc. · 2026
  • K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K081426 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081426: Nexstar Liftoff Pet Application Software Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081426

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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