510(k) Report

510(k) · Cleared

Cleared

PennPET Explorer Positron Emission Tomograph

K251401510(k) TraditionalCleared Nov 25, 2025203-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

Trustees of the University of Pennsylvania · KPS System, Tomography, Computed, Emission

Cleared on Nov 25, 2025 as substantially equivalent to K123599 (Philips Healthcare (Cleveland), 2013) after a 203-day review. Its family tree reaches back 10 generations to 1993.

Decided
Nov 25, 2025
Review
203 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K930090 (1993). 23 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 ancestorsReference device: K172406 · Ingenuity TF · Philips Medical Systems (Cleveland), Inc. · 2017 · recalledReference device: K081135 · Gemini Condor · Philips Medical Systems (Cleveland), Inc. · 2008 · recalledK930090 · 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 · recalled×2: 2 generations cleared close together, K041955 (2004), K042935 (2004) ×2: 2 generations cleared close together, K051170 (2005), K052640 (2005) K123599 · Ingenuity Digital Pet/CT · Philips Healthcare (Cleveland) · 2013 · recalled1990200020102020
Other ancestors, by generation 4 generations back: 1 other ancestor5 generations back: 1 other ancestor6 generations back: 2 other ancestors7 generations back: 6 other ancestors8 generations back: 3 other ancestors K123599 · Ingenuity Digital Pet/CT · Philips Healthcare (Cleveland) · 2013 · recalledK052640 · 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. · 1993−10−50
  1. Root · 10 generations backK930090 HelicatElscint, Inc. · 1993
  2. 6 generations between
  3. 3 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  4. 2 generations backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  5. 1 generation backK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
  6. This deviceK251401 PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania · 2025
Show all 10 generations
  1. Root · 10 generations backK930090 HelicatElscint, Inc. · 1993
  2. 9 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
  3. 8 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
  4. 7 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
  5. 6 generations backK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
  6. 5 generations backK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  7. 4 generations backK042935 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  8. 3 generations backK051170 Gemini GXLPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  9. 2 generations backK052640 Gemini RaptorPhilips Medical Systems (Cleveland), Inc. · 2005 · Recalled
  10. 1 generation backK123599 Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland) · 2013 · Recalled
  11. This deviceK251401 PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K930090HelicatElscint, Inc.1993—
−9K961464Select/SPElscint, Inc.19963
−8K982060Volumax CT Imaging SystemElscint, Inc.1998—
−7K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200161
−6K032036Gemini 16Philips Medical Systems (Cleveland), Inc.20032
−5K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc.20042
−4K042935Gemini GXLPhilips Medical Systems (Cleveland), Inc.20042
−3K051170Gemini GXLPhilips Medical Systems (Cleveland), Inc.200512
−2K052640Gemini RaptorPhilips Medical Systems (Cleveland), Inc.200536
−1K123599Ingenuity Digital Pet/CTPhilips Healthcare (Cleveland)20135
0 (this device)K251401PennPET Explorer Positron Emission TomographTrustees of the University of Pennsylvania2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199510
199710
200020
200130
200330
200410
FIG. 1 — Lineage of K251401, 1993–2025Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K123599Ingenuity Digital Pet/CT
Summary page 5
…21 CFR 892.1750 Primary Product Code: KPS Secondary Product Code: JAK Device Class: Class II Predicate Device: K123599, Ingenuity TF Digital (Vereos) PET/CT System Reference Devices: K172406, Ingenuity TF PET/CT System…
Philips Healthcare (Cleveland)20135
†K172406Ingenuity TFPhilips Medical Systems (Cleveland), Inc.20173
†K081135Gemini CondorPhilips Medical Systems (Cleveland), Inc.200813

Also cleared against K123599: 1 other device →

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 32 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
  • 14 of the 23 ancestors have a recall of any class.
  • 1 other device also cites its predicate K123599.

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. 2025, 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?

The PennPET Explorer PET system is a diagnostic imaging device that, together with the co-located IQon CT scanner, combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The IQon CT system images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET system images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. Together, these systems are used for the…

Read the full statement (135 words)

The PennPET Explorer PET system is a diagnostic imaging device that, together with the co-located IQon CT scanner, combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The IQon CT system images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET system images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. Together, these systems are used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology.

The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. The CT scanner can also be operated as fully functional, independent diagnostic tool, including for use in radiation therapy planning.

Indications for use as stated in the FDA summary.

Also cleared against K123599

1 other device cites the same predicate.

  • K210880Vereos PET/CTPhilips Medical Systems Nederland B.V. · 2021

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/K251401 · printed Nov 5, 2026

Cite this page

510(k) Report. “K251401: PennPET Explorer Positron Emission Tomograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251401

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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