510(k) Report

510(k) · Cleared

Cleared

QPS/BPGS/Moco Processing Applications for Entegra Workstation

K003264510(k) TraditionalCleared Dec 21, 200064-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

Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission

Cleared on Dec 21, 2000 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 25 later devices descend from it.

Decided
Dec 21, 2000
Review
64 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
0

25 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2005: 1 descendant cleared2002: 2 descendants cleared2004: 1 descendant cleared2008: 2 descendants cleared2007: 2 descendants cleared2016: 2 descendants cleared2022: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2021: 1 descendant cleared2018: 2 descendants cleared2013: 1 descendant cleared2025: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003264 QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 2000
  2. Descendant · cites it directly · 9 of its ownK110507 Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011
  3. Descendant · cites it directly · 9 of its ownK023110 Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp. · 2002
  4. Descendant · cites it directly · 7 of its ownK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
  5. Descendant · 2 generations on · 6 of its ownK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
  6. Descendant · 2 generations on · 5 of its ownK161740 D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2002: 22004: 12005: 12006: 12007: 22008: 22009: 12010: 12011: 32013: 12016: 22018: 22019: 12021: 12022: 12023: 12025: 12026: 1
2002high 3 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 25 · See all
  • K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd. · 2011 · cites it directly9descendants
  • K023110Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp. · 2002 · cites it directly9descendants
  • K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005 · cites it directly7descendants
  • K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007 · 2 generations on6descendants
  • K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. · 2016 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003264QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa2000—
+1K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.2011—
+1K023110Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp.2002—
+1K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.2005—
+2K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp.2007—
+2K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
200510
200610
200720
200820
200910
201010
201130
201310
201620
201820
201910
202110
202210
202310
202510
202610
FIG. 1 — Lineage of K003264, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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 18.7 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (25)

See all 25

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110507Cardiac Scanner and Processing SystemSpectrum Dynamics (Israel), Ltd.20119
K023110Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp.20029
K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp.20057
K022428Quantitative Blood Pool Spect (QBS)Adac Laboratories20024

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?

  • Of its descendants, K110507 (Spectrum Dynamics (Israel), Ltd., 2011) has gone furthest, with 9 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—

More from Ge Medical Systems F.I. Haifa

17 FDA decisions under this applicant name. See the company

  • K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 2013
  • K093982Xeleris 3 Processing and Review WorkstationGe Medical Systems F.I. Haifa · 20101 recall
  • K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 20092 Class I recalls
  • K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 20081 recall
  • K080124Ventri 1.1Ge Medical Systems F.I. Haifa · 20082 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/K003264 · printed Nov 3, 2026

Cite this page

510(k) Report. “K003264: QPS/BPGS/Moco Processing Applications for Entegra Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K003264

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026