# K113248: Aerodr System with P-21

- Pathway: 510(k) (Special)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Jan 17, 2012 after 75 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: 6 generations back to K981556 (1998). 7 ancestors in all.
14 later devices descend from it; 3 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)
- K102349: Aerodr System, Konica Minolta Medical & Graphic, Inc. (2010) Summary page 1.

## Most influential descendants
- K141271: Aerodr System 2 (2014), 12 descendants of its own
- K162504: SKR 3000 (2016), 8 descendants of its own
- K172793: SKR 3000 (2017), 5 descendants of its own
- K182688: SKR 3000 (2018), 4 descendants of its own
- K210619: SKR 3000 (2021), 2 descendants of its own

## Indications for use
The AeroDR SYSTEM with P-21 is Indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Source page: https://510kreport.com/device/K113248
Methodology: https://510kreport.com/methodology