510(k) · Cleared

Cleared

Modification to Scintron IV

K101013510(k) SpecialCleared Jun 7, 201056-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

Miegmbh · KPS System, Tomography, Computed, Emission

Cleared on Jun 7, 2010 as substantially equivalent to K953193 (Medical Imaging Electronics America, Inc., 1995) and 3 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1995. 1 of the 19 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Jun 7, 2010
Review: 56 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K952674 (1995). 17 ancestors in all, the oldest K892358 (1989). 1 later device descends from it, 1 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 4 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
3 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
2 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
1 generation backK023190 E.Cam Computer / E.Soft WorkstationSiemens Medical Solutions USA, Inc. · 2002
This deviceK101013 Modification to Scintron IVMiegmbh · 2010
Descendant · cites it directly · 0 of its ownK101768 Mie Scintron Gamma Camera SystemsMiegmbh · 2010

Class I recalls in this family

K991841 Hawkeye Option for Dual-Head Variable Angle…2 generations back · 1999

Most influential descendants

Showing 1 of 1 · See all

K101768Mie Scintron Gamma Camera SystemsMiegmbh · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−3	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
−2	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	Class I
−1	K023190	E.Cam Computer / E.Soft Workstation	Siemens Medical Solutions USA, Inc.	2002	—
0 (this device)	K101013	Modification to Scintron IV	Miegmbh	2010	—
+1	K101768	Mie Scintron Gamma Camera Systems	Miegmbh	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	2	0
1995	3	0
1996	1	0
1997	1	0
1999	2	0
2000	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K101013, 1995–2010Source: 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.

1 device in this family has 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 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? (4)

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
*	K953193	Scintron IV Summary page 1 …Class II Identification of Legally Market and Equivalent Devices 510(k) # Device Manufacturer K953193 SCINTRON IV MiE GmbH /MjEAmerica Inc. K0231 90 E.CAM Computer I e.soft Workstation…	Medical Imaging Electronics America, Inc.	1995	—
*	K023190	E.Cam Computer / E.Soft Workstation Summary page 1 …510(k) # Device Manufacturer K953193 SCINTRON IV MiE GmbH /MjEAmerica Inc. K0231 90 E.CAM Computer I e.soft Workstation Siemens Medical Solutions ISA, Inc. K914350 ICON COMPUTER SYSTEM…	Siemens Medical Solutions USA, Inc.	2002	—
*	K914350	Icon Computer System Summary page 1 …SCINTRON IV MiE GmbH /MjEAmerica Inc. K0231 90 E.CAM Computer I e.soft Workstation Siemens Medical Solutions ISA, Inc. K914350 ICON COMPUTER SYSTEM Siemens Gammasonics, Inc. K080575 Conidor4DM…	Siemens Gammasonics, Inc.	1991	1
*	K080575	CORRIDOR4DM Summary page 1 …E.CAM Computer I e.soft Workstation Siemens Medical Solutions ISA, Inc. K914350 ICON COMPUTER SYSTEM Siemens Gammasonics, Inc. K080575 Conidor4DM INVIA, LCC Special 510(k) SCINTRON Summary 2010-03-23.dc/ TK…	Invia	2008	—

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
K101768	Mie Scintron Gamma Camera Systems	Miegmbh	2010	0

Has anything in its family been recalled? (1 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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
7 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K101768 (Miegmbh, 2010) 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. 2010, 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?

The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras. The SCINTRON is used to perform static, dynamic and gated studies, as well as SPECT (non positron emitting tomography), whole body or planar. procedure, on standing, seated or recumbent patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101013 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101013: Modification to Scintron IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101013

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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