# K943581: Hydradjust IV Urological Table

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Group, Inc.
- Decided: Jan 4, 1995 after 166 days
- Product code: IXR (Table, Radiographic, Tilting)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
50 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011311: Urologic (2001), 47 descendants of its own
- K042236: G-SCAN (2004), 45 descendants of its own
- K060956: G-Scan-Model 9800020000, E-Scan Model 9800010000 and E-Scan XQ-Models-9800010011/9800010005,9800010009/9800010004 (2006), 43 descendants of its own
- K063207: S-Scan Mri System (2006), 34 descendants of its own
- K061429: Dynamic Mri Software Option for C-Scan, E-Scan XQ and E-Scan Opera (2006), 32 descendants of its own

## Recalls of this device
- Feb 27, 2017 · Class II · Z-2833-2018: Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than
- Apr 25, 2013 · Class II · Z-1753-2013: A complaint was received in which a hospital physicist indicated the dosage was too high on the HUT system. During the service call the systems Maximum Fluoro Dose was found to be 30 R/min which is th
- Jun 14, 2010 · Not classified · Z-1904-2010: Covidien received complaints of the Sedecal Generator failing and producing smoke at customer sites. The failure modes are located in different parts of the generator and will lead to the generator be

Source page: https://510kreport.com/device/K943581
Methodology: https://510kreport.com/methodology