# K102349: Aerodr System

- Pathway: 510(k) (Traditional)
- Applicant: Konica Minolta Medical & Graphic, Inc.
- Decided: Nov 24, 2010 after 97 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: 5 generations back to K981556 (1998). 6 ancestors in all.
22 later devices descend from it; 7 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082347: Digital Radiography, Flexdr C30, Konica Minolta Technoproduct Co., Ltd. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K080318: Alma Laser Nir Module, Alma Lasers, Ltd. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K120477: Aerosync for Aerodr System (2012), 14 descendants of its own
- K113248: Aerodr System with P-21 (2012), 14 descendants of its own
- K130936: Aerodr System with P-31 (2013), 13 descendants of its own
- K141271: Aerodr System 2 (2014), 12 descendants of its own
- K162504: SKR 3000 (2016), 8 descendants of its own

## Indications for use
The AeroDR SYSTEM 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 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Source page: https://510kreport.com/device/K102349
Methodology: https://510kreport.com/methodology