510(k) Report

510(k) · Cleared

Cleared

Penn-Pet Scanner

K930428510(k) TraditionalCleared Jun 8, 1993133-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

Ugm Medical Systems, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Jun 8, 1993 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jun 8, 1993
Review
133 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 2 descendants cleared1998: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK930428 Penn-Pet ScannerUgm Medical Systems, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK973396 Quest Pet Imaging SystemUgm Medical Systems, Inc. · 1998
  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 ownK042839 C-Pet Plus Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004
  5. 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 4 of 4 · See all
  • K973396Quest Pet Imaging SystemUgm Medical Systems, Inc. · 1998 · cites it directly1descendant
  • K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 1997 · cites it directly1descendant
  • K042839C-Pet Plus Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · 2 generations on0descendants
  • 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)K930428Penn-Pet ScannerUgm Medical Systems, Inc.1993—
+1K973396Quest Pet Imaging SystemUgm Medical Systems, Inc.1998—
+1K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America1997—
+2K042839C-Pet Plus Imaging SystemPhilips Medical Systems (Cleveland), Inc.2004—
+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
199720
199810
200410
FIG. 1 — Lineage of K930428, 1993–2004Source: 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), 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
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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? (4)

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

NumberDeviceApplicantDecidedDescendants
K973396Quest Pet Imaging SystemUgm Medical Systems, Inc.19981
K963273Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America19971
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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K973396 (Ugm Medical Systems, Inc., 1998) has gone furthest, with 1 descendant 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 Ugm Medical Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K973396Quest Pet Imaging SystemUgm Medical Systems, Inc. · 1998
  • K945721Penn-Pet ScannerUgm Medical Systems, Inc. · 1995
  • K890100Penn-Pet ScannerUgm Medical Systems, 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/K930428 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930428: Penn-Pet Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930428

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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