510(k) · Cleared

Cleared

E.Cam Computer / E.Soft Workstation

K023190510(k) SpecialCleared Oct 24, 200229-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 24, 2002 as substantially equivalent to K992731 (Siemens Medical Solutions USA, Inc., 1999) and 4 other predicates after a 29-day review. Its family tree reaches back 3 generations to 1995. 7 of the 113 devices in its family, counting itself, have a Class I recall. 104 later devices descend from it.

Decided: Oct 24, 2002
Review: 29 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K952674 (1995). 8 ancestors in all, the oldest K892358 (1989). 104 later devices descend from it, 6 citing it directly. 7 of the 113 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
2 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
1 generation backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
This deviceK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 86 of its ownK063826 Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007
Descendant · 2 generations on · 85 of its ownK072567 Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · Recalled
Descendant · 2 generations on · 83 of its ownK082506 Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · Recalled
Descendant · 3 generations on · 66 of its ownK131634 SymbiaSiemens Medical Solutions USA, Inc. · 2013 · Recalled
Descendant · 4 generations on · 65 of its ownK142006 Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · Recalled

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

2007high 14 (2025) · low 1 (2008)2026

Class I recalls in this family

K991841 Hawkeye Option for Dual-Head Variable Angle…direct predicate · 1999
K093514 Discovery Model NM/CT 6703 generations on · 2009
K153402 Discovery NM/CT 670 CZT4 generations on · 2016
K173816 NM/CT 850, NM/CT 8604 generations on · 2018

Most influential descendants

Showing 5 of 104 · See all

K063826Syngo MI Applications 2007ASiemens Medical Solutions USA, Inc. · 2007 · cites it directly86descendants
K072567Symbia-E, Model 10275879Siemens Medical Solutions USA, Inc. · 2007 · 2 generations on85descendants
K082506Symbia, Version 4.0Siemens Medical Solutions USA, Inc. · 2008 · 2 generations on83descendants
K131634SymbiaSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on66descendants
K142006Symbia 6.0Siemens Medical Solutions USA, Inc. · 2014 · 4 generations on65descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−2	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
−1	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	Class I
0 (this device)	K023190	E.Cam Computer / E.Soft Workstation	Siemens Medical Solutions USA, Inc.	2002	—
+1	K063826	Syngo MI Applications 2007A	Siemens Medical Solutions USA, Inc.	2007	—
+2	K072567	Symbia-E, Model 10275879	Siemens Medical Solutions USA, Inc.	2007	2
+2	K082506	Symbia, Version 4.0	Siemens Medical Solutions USA, Inc.	2008	9
+3	K131634	Symbia	Siemens Medical Solutions USA, Inc.	2013	7
+4	K142006	Symbia 6.0	Siemens Medical Solutions USA, Inc.	2014	9

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	1	0
1995	1	0
1999	1	0
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2008	1	0
2009	1	1
2010	4	0
2011	3	2
2012	2	1
2013	3	0
2014	1	0
2015	1	0
2016	3	1
2017	2	0
2018	6	1
2019	3	0
2020	6	0
2021	11	0
2022	7	0
2023	12	0
2024	10	0
2025	14	0
2026	12	0

FIG. 1 — Lineage of K023190, 1995–2026Source: 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.

7 devices in this family have a Class I recall. 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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
*	K992731	E.Cam Computer Summary page 1 …evices Device Manufacturer 51O(k) Number E.CAM Computer Siemens Medical Solutions USA, Inc. K992731 ICON Computer System Siemens Medical Solutions USA, Inc. K903315B ADAC Pegasys Phillips Medica…	Siemens Medical Solutions USA, Inc.	1999	1
*	K903315	ICON Summary page 1 …51O(k) Number E.CAM Computer Siemens Medical Solutions USA, Inc. K992731 ICON Computer System Siemens Medical Solutions USA, Inc. K903315B ADAC Pegasys Phillips Medical Systems K892358 Hawkeye Option for Dual- EL GEMS Ltd./ G…	Siemens Gammasonics, Inc.	1991	1
*	K892358	Pegasys Nuclear Medicine Imaging Computer Summary page 1 …. K992731 ICON Computer System Siemens Medical Solutions USA, Inc. K903315B ADAC Pegasys Phillips Medical Systems K892358 Hawkeye Option for Dual- EL GEMS Ltd./ GE Medical K991841 Headed Variable Angle Gamma Camera ECAT PET SC…	Adac Laboratories	1989	—
*	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera Summary page 1 …. K903315B ADAC Pegasys Phillips Medical Systems K892358 Hawkeye Option for Dual- EL GEMS Ltd./ GE Medical K991841 Headed Variable Angle Gamma Camera ECAT PET SCANNER CTI PET Systems, Inc. KO027 1 5 === Page…	Ge Medical Systems F.I. Haifa	1999	Class I
*	K002715	Ecat Pet Scanner	Cti Pet Systems, Inc.	2000	2

Also cleared against K992731: 4 other devices →

What descends from it? (104)

See all 104

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

Number	Device	Applicant	Decided	Descendants
K063826	Syngo MI Applications 2007A	Siemens Medical Solutions USA, Inc.	2007	86
K180815	MIM - SPECTRA Quant	Mim Software, Inc.	2018	54
K101279	CORRIDOR4DM V2010 Model: V2010	Invia	2010	12
K152503	ImagenSPECT	Cardiovascular Imaging Technologies	2016	1
K101013	Modification to Scintron IV	Miegmbh	2010	1
K201933	ImagenSPECT 3.0	Cardiovascular Imaging Technologies	2020	0

Has anything in its family been recalled? (7 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K093514Discovery Model NM/CT 670Ge Medical Systems F.I. Haifa · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
K153402Discovery NM/CT 670 CZTGE Healthcare · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
K173816NM/CT 850, NM/CT 860GE Healthcare · 2018 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K111445Discovery NM 630GE Healthcare · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K113350Brivo NM 615GE Healthcare · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
K121019Optima NM/CT 640GE Healthcare · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls

Nearest 5 of 7; all are on the web page.

What does this lineage say?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
6 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K063826 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 86 descendants of its own.
4 other devices also cite its predicate K992731.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

E.CAM Computer / e.soft Workstation is a Gamma Camera computer for nuclear medicine used to detect or image the distribution of radionuclides in the body or organ, using the following techniques

Planar Imaging

Whole body itnaging

Tomographic imaging (SPECT) for non positron emitter

Positron imaging by coincidence

Positron imaging without coincidence up to 588 keV

Display and process nuclear medicine, PET and CT images

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023190 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023190: E.Cam Computer / E.Soft Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023190

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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