# K152767: OTC12D Auto Radiographic System

- Pathway: 510(k) (Abbreviated)
- Applicant: Del Medical, Inc.
- Decided: Dec 14, 2015 after 81 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: 10 generations back to K801623 (1980). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121513: Multix Fusion, Siemens Medical Solution (2012) Summary page 4.

## Most influential descendants
- K223550: DMX (2023), 0 descendants of its own

## Indications for use
The OTCI12D Auto System is a radiographic system used in hospitals, clinics, and medical practices. The OTC12D Auto System enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult, and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critically ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The OTC12D Auto System is not meant for mammography. The OTC12D Auto System can use a mobile (wired) or portable (wireless) digital detector (not provided with system) for generating diagnostic images by converting x-rays into electronic signals. The OTC12D Auto System is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Source page: https://510kreport.com/device/K152767
Methodology: https://510kreport.com/methodology