510(k) Report

510(k) · Cleared

Cleared

Sim-400 System

K931193510(k) TraditionalCleared Jun 21, 1993104-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

Scinticor, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Jun 21, 1993 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 21, 1993
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 2003: 1 descendant cleared2007: 1 descendant cleared2005: 1 descendant cleared1990200020102020
  1. This deviceK931193 Sim-400 SystemScinticor, Inc. · 1993
  2. Descendant · cites it directly · 2 of its ownK023373 Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners · 2003 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK072191 Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners · 2007
  4. Descendant · 2 generations on · 0 of its ownK051402 Onepass Nuclear Medicine Imaging SystemGvi Technology Partners · 2005

Most influential descendants

Showing 3 of 3 · See all
  • K023373Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners · 2003 · cites it directly2descendants
  • K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners · 2007 · 2 generations on0descendants
  • K051402Onepass Nuclear Medicine Imaging SystemGvi Technology Partners · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K931193Sim-400 SystemScinticor, Inc.1993—
+1K023373Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners20031
+2K072191Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners2007—
+2K051402Onepass Nuclear Medicine Imaging SystemGvi Technology Partners2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200710
FIG. 1 — Lineage of K931193, 1993–2007Source: 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 18.6 · 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K023373Onepass Nuclear Imaging System, Model 70-500101Gvi Technology Partners20032

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, K023373 (Gvi Technology Partners, 2003) 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 Scinticor, Inc.

2 FDA decisions under this applicant name. See the company

  • K885054System Seventy SevenScinticor, Inc. · 1989

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/K931193 · printed Nov 6, 2026

Cite this page

510(k) Report. “K931193: Sim-400 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931193

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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