510(k) · Cleared

Recalled · 2010

Carbon Fiber Conformal Couch Top

K973842510(k) TraditionalCleared Dec 5, 199758-day reviewClass II21 CFR 892.1980Recalls 7

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

Medtec, Inc. · IXQ Table, Radiographic, Stationary Top

Cleared on Dec 5, 1997 after a 58-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it. It has been recalled 7 times.

Decided: Dec 5, 1997
Review: 58 days
Class: Class II
Product code: IXQ
Recalls: 7
Predicates: 0

23 later devices descend from it, 5 citing it directly.

This deviceK973842 Carbon Fiber Conformal Couch TopMedtec, Inc. · 1997
Descendant · cites it directly · 15 of its ownK080072 Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008
Descendant · cites it directly · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
Descendant · 2 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
Descendant · cites it directly · 9 of its ownK040773 Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004
Descendant · 2 generations on · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2004high 3 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 23 · See all

K080072Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008 · cites it directly15descendants
K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · cites it directly14descendants
K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 2 generations on13descendants
K040773Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004 · cites it directly9descendants
K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973842	Carbon Fiber Conformal Couch Top	Medtec, Inc.	1997	—
+1	K080072	Mri Patient Positioning Devices	CIVCO Medical Instruments Co., Inc.	2008	—
+1	K093738	Mri Patient Positioning Devices	Medtec, Inc.	2010	—
+2	K111340	Head and Neck Immobilization System, Body Immobilization System	Medtec, Inc.	2011	—
+1	K040773	Pelvis Bellyboard Plus Patient Positioning System	Bionix Development Corp.	2004	—
+2	K142420	Patient Positioning Devices	Macromedics BV	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	3	0
2015	1	0
2016	3	0
2017	1	0
2018	2	0
2020	1	0
2021	2	0
2022	2	0
2023	2	0
2025	1	0

FIG. 1 — Lineage of K973842, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K080072	Mri Patient Positioning Devices	CIVCO Medical Instruments Co., Inc.	2008	15
K093738	Mri Patient Positioning Devices	Medtec, Inc.	2010	14
K040773	Pelvis Bellyboard Plus Patient Positioning System	Bionix Development Corp.	2004	9
K180021	Proton Positioing and Immobilization Devices	Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap	2018	5
K121545	Bellyboard, SBRT Accessories	Medtec Inc. Dba Civco Medical Solutions	2012	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 30, 2010	Not classified	Z-3020-2011	Nonconforming Material/Component	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Dec 30, 2010	Not classified	Z-3019-2011	Nonconforming Material/Component	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Dec 30, 2010	Not classified	Z-3021-2011	Nonconforming Material/Component	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Jun 21, 2010	Not classified	Z-0395-2011	Device Design	Under certain conditions, the extensions can become detached from the main body of the couch.
Jun 21, 2010	Not classified	Z-0396-2011	Device Design	Under certain conditions, the extensions can become detached from the main body of the couch.
Jun 21, 2010	Not classified	Z-0394-2011	Device Design	Under certain conditions, the extensions can become detached from the main body of the couch.
Mar 6, 2009	Not classified	Z-1721-2009	Error in labeling	The silkscreened indexing scale was reversed.

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K080072 (CIVCO Medical Instruments Co., Inc., 2008) has gone furthest, with 15 descendants of its own.

How does its category compare?

All IXQ devices

IXQ Table, Radiographic, Stationary Top: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXQ

FDA has decided no IXQ device since 2007.

Median 510(k) review, days · IXQ

Too few IXQ 510(k)s in any year since 2007 to give a median.

Recalls per year · IXQ

6in 2010

2007high 6 (2010) · low 0 (2007)2026

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

Adverse event reports per year · IXQ

2in 2018

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code IXQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	1	0
2010	—	6	1
2011	—	0	1
2012	—	0	0
2013	—	0	0
2014	—	0	1
2015	—	0	1
2016	—	0	1
2017	—	0	0
2018	—	0	2
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	0	0
2025	—	0	0
2026	—	0	—

What is it indicated for?

MED-TEC, INC. has a Table, Radiographic, Stationary Top System to be manufactured by MED-TEC, INC.

Classification Name: Table Top

Common/Usual Name: Table, Radiographic, Stationary Top

Proprietary Name: Carbon Fiber Conformal Couch Top

The MED-TEC, INC. Carbon Fiber Conformal Couch Top operates in the same manner as an ordinary couch. The intended use of the MED-TEC, INC. Carbon Fiber Conformal Couch Top is to support and aid in positioning a patient during radiologic and other medical procedures.

Classification: Since this device is used with Class II equipment, we believe the Carbon Fiber Conformal Couch Top to be a Class II device.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973842 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973842: Carbon Fiber Conformal Couch Top.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973842

Report an extraction error

Are you the manufacturer?

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