510(k) · Cleared

Cleared

E.Cam Lso 311 Pet/Spect System

K981027510(k) TraditionalCleared Jun 8, 199881-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

Cti Pet Systems, Inc. · KPS System, Tomography, Computed, Emission

Cleared on Jun 8, 1998 as substantially equivalent to K952109 (Siemens Medical Solutions USA, Inc., 1995) and 4 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.

Decided: Jun 8, 1998
Review: 81 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K914350 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK914350 Icon Computer SystemSiemens Gammasonics, Inc. · 1991 · Recalled
This deviceK981027 E.Cam Lso 311 Pet/Spect SystemCti Pet Systems, Inc. · 1998
Descendant · cites it directly · 0 of its ownK040933 Ecat HRRTCti Pet Systems, Inc. · 2004
Descendant · cites it directly · 0 of its ownK021633 Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all

K040933Ecat HRRTCti Pet Systems, Inc. · 2004 · cites it directly0descendants
K021633Ecat Vision Pet Scanner, Models 3000 & 5000Cti Pet Systems, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K914350	Icon Computer System	Siemens Gammasonics, Inc.	1991	1
0 (this device)	K981027	E.Cam Lso 311 Pet/Spect System	Cti Pet Systems, Inc.	1998	—
+1	K040933	Ecat HRRT	Cti Pet Systems, Inc.	2004	—
+1	K021633	Ecat Vision Pet Scanner, Models 3000 & 5000	Cti Pet Systems, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0

FIG. 1 — Lineage of K981027, 1991–2004Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K952109	IP500 Nuclear Gamma Camera System Summary page 1 …Computed Tomography System per 21CFR 892.1200 Marketed Devices to Which Equivalence is Claimed Device Manufacturer 51 umber IP500 Nuclear Camera Siemens Medical Systems K952109 ) E.CAM Coincidence Mode Option Siemens Medical Systems K970627 ICON Computer System Siemens Medical Systems K914350 ECAT EXACT…	Siemens Medical Solutions USA, Inc.	1995	7
*	K970627	E. Cam Coincidence Mode (CM) Summary page 1 …to Which Equivalence is Claimed Device Manufacturer 51 umber IP500 Nuclear Camera Siemens Medical Systems K952109 ) E.CAM Coincidence Mode Option Siemens Medical Systems K970627 ICON Computer System Siemens Medical Systems K914350 ECAT EXACT & ECAT EXACT HR+ CTI PET Systems K962797 ECAT PET Scanner System…	Siemens Medical Solutions USA, Inc.	1997	—
*	K914350	Icon Computer System Summary page 1 …umber IP500 Nuclear Camera Siemens Medical Systems K952109 ) E.CAM Coincidence Mode Option Siemens Medical Systems K970627 ICON Computer System Siemens Medical Systems K914350 ECAT EXACT & ECAT EXACT HR+ CTI PET Systems K962797 ECAT PET Scanner System & Software V7.1 CTI PET Systems K974256 DeviceDeéscri…	Siemens Gammasonics, Inc.	1991	1
*	K962797	Ecat Exact & Ecat Exact HR+ Summary page 1 …K952109 ) E.CAM Coincidence Mode Option Siemens Medical Systems K970627 ICON Computer System Siemens Medical Systems K914350 ECAT EXACT & ECAT EXACT HR+ CTI PET Systems K962797 ECAT PET Scanner System & Software V7.1 CTI PET Systems K974256 DeviceDeéscripti The E.CAM LSO 311 PET/SPECT system is a dual de…	Cti Pet Systems, Inc.	1996	14
*	K974256	Ecat Pet Scanners Summary page 1 …K970627 ICON Computer System Siemens Medical Systems K914350 ECAT EXACT & ECAT EXACT HR+ CTI PET Systems K962797 ECAT PET Scanner System & Software V7.1 CTI PET Systems K974256 DeviceDeéscripti The E.CAM LSO 311 PET/SPECT system is a dual detector head nuclear camera having the purpose of performing a fu…	Cti Pet Systems, Inc.	1998	—

Also cleared against K952109: 3 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K040933	Ecat HRRT	Cti Pet Systems, Inc.	2004	0
K021633	Ecat Vision Pet Scanner, Models 3000 & 5000	Cti Pet Systems, Inc.	2002	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?

3 of the 5 ancestors have a recall of any class.
Of its descendants, K040933 (Cti Pet Systems, Inc., 2004) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K952109.

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 Siemens/CPS E.CAM LSO 311 PET/SPECT System is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected single photon radiopharmaceuticals and positron emitting radiopharmaceuticals in humans for use in the determination of various metabolic and physiologic functions within the human body and in the diagnosis of certain disease conditions in various organs, tissues and other anatomical structures.

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/K981027 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981027: E.Cam Lso 311 Pet/Spect System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981027

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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