510(k) Report

510(k) · Cleared

Cleared

Ecat Pet Scanners

K974256510(k) TraditionalCleared Feb 25, 1998104-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

Cti Pet Systems, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Feb 25, 1998 after a 104-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided
Feb 25, 1998
Review
104 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2004: 1 descendant cleared2002: 1 descendant cleared1995200020052010201520202025
  1. This deviceK974256 Ecat Pet ScannersCti Pet Systems, Inc. · 1998
  2. Descendant · cites it directly · 2 of its ownK981027 E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998
  3. Descendant · 2 generations on · 0 of its ownK040933 Ecat HRRTCti Pet Systems, Inc. · 2004
  4. Descendant · 2 generations on · 0 of its ownK021633 Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002

Most influential descendants

Showing 3 of 3 · See all
  • K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998 · cites it directly2descendants
  • K040933Ecat HRRTCti Pet Systems, Inc. · 2004 · 2 generations on0descendants
  • K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K974256Ecat Pet ScannersCti Pet Systems, Inc.1998—
+1K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc.1998—
+2K040933Ecat HRRTCti Pet Systems, Inc.2004—
+2K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200410
FIG. 1 — Lineage of K974256, 1998–2004Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc.19982

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, K981027 (Cti Pet Systems, Inc., 1998) has gone furthest, with 2 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 Cti Pet Systems, Inc.

19 FDA decisions under this applicant name. See the company

  • K050509Lso Pet/CT Hirez Series, Models 2I, 6I, 16I, 64ICti Pet Systems, Inc. · 2005
  • K042467Lso Pet/CT Hirez 64Cti Pet Systems, Inc. · 20041 recall
  • K040933Ecat HRRTCti Pet Systems, Inc. · 2004
  • K033431Lso Pet/CT Hirez and Lso Pet/CT 16 HirezCti Pet Systems, Inc. · 20031 recall
  • K023768Ecat Pet/CT; Ecat Lso Pet/CT; Ecat Lso Pet/CT 16Cti Pet Systems, Inc. · 2002

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/K974256 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974256: Ecat Pet Scanners.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974256

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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