510(k) Report

510(k) · Cleared

Recalled · 2007

Ecat Exact & Ecat Exact HR+

K962797510(k) TraditionalCleared Oct 15, 199689-day reviewClass II21 CFR 892.1200Recalls 14

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 Oct 15, 1996 after an 89-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it. It has been recalled 14 times.

Decided
Oct 15, 1996
Review
89 days
Class
Class II
Product code
KPS
Recalls
14
Predicates
0

6 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2013: 1 descendant cleared1998: 2 descendants cleared2002: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962797 Ecat Exact & Ecat Exact HR+Cti Pet Systems, Inc. · 1996
  2. Descendant · cites it directly · 2 of its ownK981027 E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998
  3. Descendant · cites it directly · 1 of its ownK130269 Ecat Scintron PetMiegmbh · 2013
  4. Descendant · 2 generations on · 0 of its ownK201807 AncorisMiegmbh · 2020
  5. Descendant · cites it directly · 0 of its ownK040933 Ecat HRRTCti Pet Systems, Inc. · 2004
  6. Descendant · cites it directly · 0 of its ownK021633 Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998: 22002: 12004: 12013: 12020: 1
1998high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 6 · See all
  • K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998 · cites it directly2descendants
  • K130269Ecat Scintron PetMiegmbh · 2013 · cites it directly1descendant
  • K201807AncorisMiegmbh · 2020 · 2 generations on0descendants
  • K040933Ecat HRRTCti Pet Systems, Inc. · 2004 · cites it directly0descendants
  • K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962797Ecat Exact & Ecat Exact HR+Cti Pet Systems, Inc.1996—
+1K981027E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc.1998—
+1K130269Ecat Scintron PetMiegmbh2013—
+2K201807AncorisMiegmbh2020—
+1K040933Ecat HRRTCti Pet Systems, Inc.2004—
+1K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
200210
200410
201310
202010
FIG. 1 — Lineage of K962797, 1996–2020Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (6)

5 later devices cite 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
K130269Ecat Scintron PetMiegmbh20131
K040933Ecat HRRTCti Pet Systems, Inc.20040
K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc.20020
K982171Hamamatsu Pet Scanner, Model SHR-22000Hamamatsu Photonics K.K.19980

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 23, 2007Not classifiedZ-0271-2008Software designIncorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
Jul 23, 2007Not classifiedZ-0273-2008Software designIncorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions followed by all emissions.
Jul 23, 2007Not classifiedZ-0251-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0252-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0270-2008Software designIncorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
Jul 23, 2007Not classifiedZ-0246-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0247-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0249-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0248-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0250-2008Software designVisual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstruction matrix sizes. (This problem…
Jul 23, 2007Not classifiedZ-0269-2008Software designIncorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
Jul 23, 2007Not classifiedZ-0272-2008Software designIncorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
Apr 5, 2005Not classifiedZ-0819-05OtherFailure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.
Mar 4, 2003Not classifiedZ-0674-03OtherIncorrect patient information is displayed in the reconstructed images of a whole body patient scan.

The 5 latest of 14 recalls; the web page lists all.

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/K962797 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962797: Ecat Exact & Ecat Exact HR+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962797

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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