510(k) Report

510(k) · Cleared

Cleared

Modification to WBR, Model HR

K031874510(k) SpecialCleared Jul 18, 200331-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

U.C.G. Technologies, Ltd. · KPS System, Tomography, Computed, Emission

Cleared on Jul 18, 2003 as substantially equivalent to K030870 (U.C.G. Technologies, Ltd., 2003) after a 31-day review. Its family tree reaches back 1 generation to 2003. 16 later devices descend from it.

Decided
Jul 18, 2003
Review
31 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K030870 (2003). 16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2011: 2 descendants cleared2005: 1 descendant cleared2008: 2 descendants cleared2009: 1 descendant cleared2016: 2 descendants cleared2021: 1 descendant cleared2018: 2 descendants cleared2025: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK030870 · WBR, Model HR · U.C.G. Technologies, Ltd. · 2003200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant K030870 · WBR, Model HR · U.C.G. Technologies, Ltd. · 20030+5+10
  1. Root · 1 generation backK030870 WBR, Model HRU.C.G. Technologies, Ltd. · 2003
  2. This deviceK031874 Modification to WBR, Model HRU.C.G. Technologies, Ltd. · 2003
  3. Descendant · cites it directly · 15 of its ownK040370 WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004
  4. Descendant · 2 generations on · 14 of its ownK050815 Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005
  5. Descendant · 3 generations on · 13 of its ownK080784 WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008
  6. Descendant · 4 generations on · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
  7. Descendant · 5 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12008: 22009: 12011: 22016: 22018: 22019: 12021: 12023: 12025: 12026: 1
2004high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 16 · See all
  • K040370WBR-FHR, WBR-FWBUltraspect, Ltd. · 2004 · cites it directly15descendants
  • K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd. · 2005 · 2 generations on14descendants
  • K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd. · 2008 · 3 generations on13descendants
  • K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · 4 generations on9descendants
  • K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K030870WBR, Model HRU.C.G. Technologies, Ltd.2003—
0 (this device)K031874Modification to WBR, Model HRU.C.G. Technologies, Ltd.2003—
+1K040370WBR-FHR, WBR-FWBUltraspect, Ltd.2004—
+2K050815Xact.Cardiac & Xpress.CardiacUltraspect, Ltd.2005—
+3K080784WBR Xpress.Cardiac, WBR Xpress.Bone; WBR Xact.Cardiac, WBR Xact.BoneUltraspect, Ltd.2008—
+4K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.2011—
+5K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200820
200910
201120
201620
201820
201910
202110
202310
202510
202610
FIG. 1 — Lineage of K031874, 2003–2026Source: 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
*K030870WBR, Model HRU.C.G. Technologies, Ltd.2003—

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040370WBR-FHR, WBR-FWBUltraspect, Ltd.200415

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?

  • Its one ancestor has no recall.
  • Of its descendants, K040370 (Ultraspect, Ltd., 2004) has gone furthest, with 15 descendants of its own.

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.

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- WB is indicated for the acquisition, formatting and storage of scintigraphy camera 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 image organs.

Indications for use as stated in the FDA summary.

More from U.C.G. Technologies, Ltd.

2 FDA decisions under this applicant name. See the company

  • K030870WBR, Model HRU.C.G. Technologies, Ltd. · 2003

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/K031874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031874: Modification to WBR, Model HR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031874

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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