# K780395: Imager, Body Section, Radionuclide

- Pathway: 510(k) (Traditional)
- Applicant: Union Carbide Corp.
- Decided: Mar 31, 1978 after 18 days
- Product code: IYW (Scanner, Rectilinear, Nuclear)
- Device class: 1
- Regulation: 21 CFR 892.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K090811: Inspira HD, Model: NL1000 (2009), 10 descendants of its own
- K102677: Bodytom NL 4000 (2011), 9 descendants of its own
- K170238: BodyTom Elite (2017), 4 descendants of its own
- K213649: BodyTom 64 (2022), 2 descendants of its own
- K131431: Airo CT System (2013), 2 descendants of its own

Source page: https://510kreport.com/device/K780395
Methodology: https://510kreport.com/methodology