510(k) · Cleared

Cleared

T-Quest System

K073456510(k) TraditionalCleared Dec 20, 200710-day reviewClass I21 CFR 892.1100

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

Medx, Inc. · IYX Camera, Scintillation (Gamma)

Cleared on Dec 20, 2007 as substantially equivalent to K052473 (Inter Medical Medizintechnik GmbH, 2005) after a 10-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.

Decided: Dec 20, 2007
Review: 10 days
Class: Class I
Product code: IYX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052473 (2005). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK052473 CX 250 C Plus with Gammaxp Software, Model 0121 0000Inter Medical Medizintechnik GmbH · 2005
This deviceK073456 T-Quest SystemMedx, Inc. · 2007
Descendant · cites it directly · 0 of its ownK101391 Scandia-45 Gamma Camera SystemScandia Corporation · 2010

Most influential descendants

Showing 1 of 1 · See all

K101391Scandia-45 Gamma Camera SystemScandia Corporation · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052473	CX 250 C Plus with Gammaxp Software, Model 0121 0000	Inter Medical Medizintechnik GmbH	2005	—
0 (this device)	K073456	T-Quest System	Medx, Inc.	2007	—
+1	K101391	Scandia-45 Gamma Camera System	Scandia Corporation	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K073456, 2005–2010Source: 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.

Planning a device in IYX? 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 IYX device

#1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
#2 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K052473	CX 250 C Plus with Gammaxp Software, Model 0121 0000 Summary page 1 …Camera System Model CX 250 C Plus. 510(k) Number K052473. Description of Device: The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantom…	Inter Medical Medizintechnik GmbH	2005	—
†	K945792	IM512P	Globus Industries	1995	—
†	K961104	Notebook Imager	Digirad Corp.	1997	—

Also cleared against K052473: 1 other device →

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
K101391	Scandia-45 Gamma Camera System	Scandia Corporation	2010	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?

Its one ancestor has no recall.
Of its descendants, K101391 (Scandia Corporation, 2010) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K052473.

How does its category compare?

All IYX devices

IYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IYX

2in 2023

2007high 4 (2010) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYX

82in 2011

2007high 82 (2010)2026

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

Recalls per year · IYX

2in 2025

2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · IYX

1in 2022

2007high 11 (2007) · low 0 (2017)2025

MAUDE reports naming product code IYX, 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	2	—	0	11
2008	2	—	0	10
2009	2	—	0	8
2010	4	82	0	5
2011	3	82	0	6
2012	0	—	0	1
2013	1	—	0	1
2014	1	—	0	3
2015	0	—	0	4
2016	2	—	0	2
2017	1	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	1
2023	2	—	0	0
2024	0	—	0	0
2025	0	—	2	0
2026	0	—	0	—

What is it indicated for?

The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073456 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073456: T-Quest System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073456

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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