510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Vertex Epic MCD

K952684510(k) TraditionalCleared Nov 24, 1995165-day reviewClass II21 CFR 892.1200Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Adac Laboratories · KPS System, Tomography, Computed, Emission

Cleared on Nov 24, 1995 after a 165-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.

Decided
Nov 24, 1995
Review
165 days
Class
Class II
Product code
KPS
Recalls
2
Predicates
0

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

Descendants, by year cleared 1999: 2 descendants cleared1997: 3 descendants cleared1995200020052010201520202025
  1. This deviceK952684 Vertex Epic MCDAdac Laboratories · 1995
  2. Descendant · cites it directly · 2 of its ownK971980 MCD-ACAdac Laboratories · 1997
  3. Descendant · cites it directly · 1 of its ownK963273 Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 1997
  4. Descendant · 2 generations on · 0 of its ownK991565 Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma…Smv America · 1999
  5. Descendant · cites it directly · 0 of its ownK991535 Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999
  6. Descendant · cites it directly · 0 of its ownK972686 Vcar Option to the DST and DST-XL Gamma Cameras and Vision…Smv America · 1997

Most influential descendants

Showing 5 of 5 · See all
  • K971980MCD-ACAdac Laboratories · 1997 · cites it directly2descendants
  • K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 1997 · cites it directly1descendant
  • K991565Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and Vision…Smv America · 1999 · 2 generations on0descendants
  • K991535Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America · 1999 · cites it directly0descendants
  • K972686Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation ComputerSmv America · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952684Vertex Epic MCDAdac Laboratories1995—
+1K971980MCD-ACAdac Laboratories1997—
+1K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America1997—
+2K991565Tac-2, Transmission Attenuation Correction and DST, DST-XL Gamma Cameras and…Smv America1999—
+1K991535Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America1999—
+1K972686Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation ComputerSmv America1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199730
199920
FIG. 1 — Lineage of K952684, 1995–1999Source: 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K971980MCD-ACAdac Laboratories19972
K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America19971
K991535Convergence CDR for Hitachi Spectradigital V250DSP Gamma CamerasHitachi Medical Corp. of America19990
K972686Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation ComputerSmv America19970

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 13, 2015Class IIZ-1598-2015Employee errorDuring clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.
Mar 10, 2014Class IIZ-1510-2014Device DesignSlippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971980 (Adac Laboratories, 1997) 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 Adac Laboratories

88 FDA decisions under this applicant name. See the company

  • K062298Apollo Gamma Camera SystemAdac Laboratories · 20061 Class I recall
  • K061029Jetstream WorkspaceAdac Laboratories · 20061 recall
  • K060020Autoquant PlusAdac Laboratories · 2006
  • K051351Precedence Spect/CT Imaging SystemAdac Laboratories · 20051 recall
  • K042880Jetstream WorkspaceAdac Laboratories · 20041 recall

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/K952684 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952684: Vertex Epic MCD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952684

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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