510(k) Report

510(k) · Cleared

Cleared

WBR Xpress Pet

K103710510(k) SpecialCleared Jan 19, 201130-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

Ultraspect, Ltd. · KPS System, Tomography, Computed, Emission

Cleared on Jan 19, 2011 as substantially equivalent to K040370 (Ultraspect, Ltd., 2004) and 3 other predicates after a 30-day review. Its family tree reaches back 7 generations to 2003.

Decided
Jan 19, 2011
Review
30 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K030870 (2003). 16 ancestors in all, the oldest K914350 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2001: 1 other ancestor1997: 1 other ancestor2000: 1 other ancestor1991: 2 other ancestorsK030870 · WBR, Model HR · U.C.G. Technologies, Ltd. · 2003K031874 · Modification to WBR, Model HR · U.C.G. Technologies, Ltd. · 2003K040370 · WBR-FHR, WBR-FWB · Ultraspect, Ltd. · 2004K050815 · Xact.Cardiac & Xpress.Cardiac · Ultraspect, Ltd. · 2005×2: 2 generations cleared close together, K080784 (2008), K081201 (2008) K091073 · WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections · Ultraspect, Ltd. · 200919901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors K091073 · WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections · Ultraspect, Ltd. · 2009K081201 · WBR XPRESS3.Cardiac · Ultraspect, Ltd. · 2008K080784 · WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone · Ultraspect, Ltd. · 2008K050815 · Xact.Cardiac & Xpress.Cardiac · Ultraspect, Ltd. · 2005K040370 · WBR-FHR, WBR-FWB · Ultraspect, Ltd. · 2004K031874 · Modification to WBR, Model HR · U.C.G. Technologies, Ltd. · 2003K030870 · WBR, Model HR · U.C.G. Technologies, Ltd. · 2003−50
  1. Root · 7 generations backK030870 WBR, Model HRU.C.G. Technologies, Ltd. · 2003
  2. 6 generations backK031874 Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 2003
  3. 5 generations backK040370 WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004
  4. 4 generations backK050815 Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005
  5. 3 generations backK080784 WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008
  6. 2 generations backK081201 WBR XPRESS3.CardiacUltraspect, Ltd. · 2008
  7. 1 generation backK091073 WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and…Ultraspect, Ltd. · 2009
  8. This deviceK103710 WBR Xpress PetUltraspect, Ltd. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K030870WBR, Model HRU.C.G. Technologies, Ltd.2003—
−6K031874Modification to WBR, Model HRU.C.G. Technologies, Ltd.2003—
−5K040370WBR-FHR, WBR-FWBUltraspect, Ltd.2004—
−4K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd.2005—
−3K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd.2008—
−2K081201WBR XPRESS3.CardiacUltraspect, Ltd.2008—
−1K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering…Ultraspect, Ltd.2009—
0 (this device)K103710WBR Xpress PetUltraspect, Ltd.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199710
200010
200110
200320
200410
200510
FIG. 1 — Lineage of K103710, 2003–2011Source: 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? (4)

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
*K040370WBR-FHR, WBR-FWB
Summary page 1
…sification: Class HI Product Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Predicate Devices WBR Xpress. Bone - K040370 &K080784 WBR Attenuation and Scattering Correction - K(091073 Work station of the GE Discovery LS - K040172 Device Description Th…
Ultraspect, Ltd.2004—
*K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.Bone
Summary page 1
…n: Class HI Product Reason for 510(k) Submission Special 510(k) Submission Identification of Legally Marketed Predicate Devices WBR Xpress. Bone - K040370 &K080784 WBR Attenuation and Scattering Correction - K(091073 Work station of the GE Discovery LS - K040172 Device Description The WBR Xpr…
Ultraspect, Ltd.2008—
*K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering Corrections
Summary page 1
…bmission Special 510(k) Submission Identification of Legally Marketed Predicate Devices WBR Xpress. Bone - K040370 &K080784 WBR Attenuation and Scattering Correction - K(091073 Work station of the GE Discovery LS - K040172 Device Description The WBR Xpress.PET is image processing system, which is interfac…
Ultraspect, Ltd.2009—
*K040172Modification to GE Discovery LS System
Summary page 1
…tion of Legally Marketed Predicate Devices WBR Xpress. Bone - K040370 &K080784 WBR Attenuation and Scattering Correction - K(091073 Work station of the GE Discovery LS - K040172 Device Description The WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstr…
GE Medical Systems20045

Also cleared against K040370: 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 8 years and passes through 2 companies; a new generation was cleared every 12 months on median.
  • 5 of the 16 ancestors have a recall of any class.
  • 1 other device also cites its predicate K040370.

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. 2011, 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 WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the

acquisition, formatting and storage of scintigraphy output data. It is capable of processing and

displaying the acquired information in traditional formats, as well as in pseudo three dimensional

renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged

organs

Indications for use as stated in the FDA summary.

Also cleared against K040370

1 other device cites the same predicate.

  • K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005

More from Ultraspect, Ltd.

6 FDA decisions under this applicant name. See the company

  • K091073WBR Xpress.Cardiac and XPRESS3.Cardiac Including Attenuation and Scattering CorrectionsUltraspect, Ltd. · 2009
  • K081201WBR XPRESS3.CardiacUltraspect, Ltd. · 2008
  • K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008
  • K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005
  • K040370WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004

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/K103710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103710: WBR Xpress Pet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103710

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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