510(k) · Cleared

Cleared

Multicam 3000 Eco

K132347510(k) TraditionalCleared Nov 20, 2013114-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

Inter Medical Medizintechnik GmbH · KPS System, Tomography, Computed, Emission

Cleared on Nov 20, 2013 as substantially equivalent to K013353 (Nuclear Cardiology Systems, Inc., 2002) and 2 other predicates after a 114-day review. Its family tree reaches back 1 generation to 1994.

Decided: Nov 20, 2013
Review: 114 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K934722 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK934722 Prism 3000 Nuclear Gamma Camera System ModificationOhio Imaging, Inc. · 1994
This deviceK132347 Multicam 3000 EcoInter Medical Medizintechnik GmbH · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934722	Prism 3000 Nuclear Gamma Camera System Modification	Ohio Imaging, Inc.	1994	—
0 (this device)	K132347	Multicam 3000 Eco	Inter Medical Medizintechnik GmbH	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0

FIG. 1 — Lineage of K132347, 1994–2013Source: 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? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K013353	Neurospectquad Gamma Camera Summary page 1 …Manufacturer Device Name 510k) Number Nuclear Cardiolog Systems Neurospect Quad Gamma Camera K013353 Ohio Imaging Prism 3000 Nuclear Gamma System jK934722 Modificati…	Nuclear Cardiology Systems, Inc.	2002	—
*	K934722	Prism 3000 Nuclear Gamma Camera System Modification Summary page 1 …mber Nuclear Cardiolog Systems Neurospect Quad Gamma Camera K013353 Ohio Imaging Prism 3000 Nuclear Gamma System jK934722 ModificationI InterMedical CX 250 C Plus with Gamma XP Software K05…	Ohio Imaging, Inc.	1994	—
*	K052473	CX 250 C Plus with Gammaxp Software, Model 0121 0000 Summary page 1 …0 Nuclear Gamma System jK934722 ModificationI InterMedical CX 250 C Plus with Gamma XP Software K052473 Device Description: 1. The MuitiCam 3000 eco consist of the gantry with 3 Gamma Camera detectors. a patient table toge…	Inter Medical Medizintechnik GmbH	2005	—

Also cleared against K013353: 1 other device →

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?

None of the 3 ancestors has a recall.
1 other device also cites its predicate K013353.

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. 2013, this device’s year, is highlighted.

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?

MultiCam 3000 eco is intended to detect and obtain Planar and SPECT images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132347 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132347: Multicam 3000 Eco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132347

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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