# K133782: Nova FA DR System

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Mar 21, 2014 after 99 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981556 (1998). 10 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090279: Sedecal, Millennium Plus, Sedecal., Sa. (2009) Summary page 1.

## Most influential descendants
- K173953: uDR 780i (2018), 2 descendants of its own
- K150816: Jumong Series (2015), 2 descendants of its own
- K143257: KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (2015), 2 descendants of its own
- K241068: uDR 780i (2024), 1 descendant of its own
- K251167: uDR Aurora CX (2025), 0 descendants of its own

## Recalls of this device
- Jul 18, 2018 · Class II · Z-0488-2019: A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm 

## Indications for use
Sedlecal "NOVA FA DR System" is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body pants. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Source page: https://510kreport.com/device/K133782
Methodology: https://510kreport.com/methodology