510(k) · Cleared

Cleared

Compact Digital Cardiac Camera (CDCC)

K033199510(k) TraditionalCleared Nov 12, 200341-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 Medical Systems, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Nov 12, 2003 after a 41-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.

Decided: Nov 12, 2003
Review: 41 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

1 later device descends from it, 1 citing it directly.

This deviceK033199 Compact Digital Cardiac Camera (CDCC)Is2 Medical Systems, Inc. · 2003
Descendant · cites it directly · 0 of its ownK040057 Mobile Compact Digital Cardiac CameraIs2 Research, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K040057Mobile Compact Digital Cardiac CameraIs2 Research, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K033199	Compact Digital Cardiac Camera (CDCC)	Is2 Medical Systems, Inc.	2003	—
+1	K040057	Mobile Compact Digital Cardiac Camera	Is2 Research, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K033199, 2003–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
#2 Held for the reportin the report
#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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K003882	FDA’s K003882 is Nucamma BI90 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Is2 Research, Inc.	2001	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K040057	Mobile Compact Digital Cardiac Camera	Is2 Research, Inc.	2004	0

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, K040057 (Is2 Research, Inc., 2004) has gone furthest, with 0 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

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KPS

16in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

To detect or image the distribution of radionuclides in the body or organ using the following technique(s): Planar Imaging; Tomographic Imaging (SPECT) for non-Positron emitter.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K033199 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033199: Compact Digital Cardiac Camera (CDCC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033199

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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