# K973842: Carbon Fiber Conformal Couch Top

- Pathway: 510(k) (Traditional)
- Applicant: Medtec, Inc.
- Decided: Dec 5, 1997 after 58 days
- Product code: IXQ (Table, Radiographic, Stationary Top)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K080072: Mri Patient Positioning Devices (2008), 15 descendants of its own
- K093738: Mri Patient Positioning Devices (2010), 14 descendants of its own
- K111340: Head and Neck Immobilization System, Body Immobilization System (2011), 13 descendants of its own
- K040773: Pelvis Bellyboard Plus Patient Positioning System (2004), 9 descendants of its own
- K142420: Patient Positioning Devices (2015), 7 descendants of its own

## Recalls of this device
- Dec 30, 2010 · Not classified · Z-3020-2011: 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: 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: 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: Under certain conditions, the extensions can become detached from the main body of the couch.
- Jun 21, 2010 · Not classified · Z-0396-2011: Under certain conditions, the extensions can become detached from the main body of the couch.
- Jun 21, 2010 · Not classified · Z-0394-2011: Under certain conditions, the extensions can become detached from the main body of the couch.
- Mar 6, 2009 · Not classified · Z-1721-2009: The silkscreened indexing scale was reversed.

## Indications for use
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.

Source page: https://510kreport.com/device/K973842
Methodology: https://510kreport.com/methodology