510(k) Report

510(k) · Cleared

Cleared

Mobile Compact Digital Cardiac Camera

K040057510(k) SpecialCleared Feb 2, 200420-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

Is2 Research, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Feb 2, 2004 as substantially equivalent to K033199 (Is2 Medical Systems, Inc., 2003) after a 20-day review. Its family tree reaches back 1 generation to 2003.

Decided
Feb 2, 2004
Review
20 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K033199 (2003). No later device cites it as a predicate yet.

K033199 · Compact Digital Cardiac Camera (CDCC) · Is2 Medical Systems, Inc. · 20032000200220042006
K033199 · Compact Digital Cardiac Camera (CDCC) · Is2 Medical Systems, Inc. · 20030
  1. Root · 1 generation backK033199 Compact Digital Cardiac Camera (CDCC)Is2 Medical Systems, Inc. · 2003
  2. This deviceK040057 Mobile Compact Digital Cardiac CameraIs2 Research, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K033199Compact Digital Cardiac Camera (CDCC)Is2 Medical Systems, Inc.2003—
0 (this device)K040057Mobile Compact Digital Cardiac CameraIs2 Research, Inc.2004—
FIG. 1 — Lineage of K040057, 2003–2004Source: 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 summary (predicates and 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
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K033199Compact Digital Cardiac Camera (CDCC)
Summary page 1
…2J1CFR 892.1200 Device Class: HI Predicate Device: Compact Digital Cardiac Camera (Predicate) 510(k) No.: K033 199 Labellin: Labels and Instructionsfor Use can be found in Attachment 1.…
Is2 Medical Systems, Inc.2003—

What descends from it?

No later submission names this one as a predicate yet.

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?

  • Its one ancestor has no recall.

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—

What is it indicated for?

The intended use of the Mobile Compact Digital Cardiac (MCDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

Indications for use as stated in the FDA summary.

More from Is2 Research, Inc.

7 FDA decisions under this applicant name. See the company

  • K033956Mobile Single Circular Camera (MSC) & Mobile Digital Cardiac Camera (MDCC)Is2 Research, Inc. · 2004
  • K032779Modification to: Nucamma RXIs2 Research, Inc. · 2003
  • K013667BCC Gamma CameraIs2 Research, Inc. · 2002
  • K003882Nucamma BI90Is2 Research, Inc. · 2001
  • K982045Nucamma RXIs2 Research, Inc. · 1998

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/K040057 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040057: Mobile Compact Digital Cardiac Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040057

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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