# K121109: Aerodr X70

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: May 23, 2012 after 41 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K042041 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073632: Intuition, Model 0170, Arcoma AB (2008) Summary page 1.

## Indications for use
AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The AeroDR X70 is not intended for mammography

Source page: https://510kreport.com/device/K121109
Methodology: https://510kreport.com/methodology