# K203010: Platinum dRF Imaging System

- Pathway: 510(k) (Special)
- Applicant: Apelem-Dms Group
- Decided: Jan 22, 2021 after 113 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160301: Platinum dRF Imaging System, Apelem-Dms Group (2016) Summary page 6.

## Indications for use
The Platinum dRF Imaging System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including: general radiology and diagnostic fluoroscopy examinations, conventional linear tomography and pediatrics examinations. The Platinum dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from, but not limited to, gastrointestinal, cranial, skeletal, thoracic, lung and urogenital tract examinations. It may also be used in: lymphography, endoscopy, myelography, venography and arthrography. The Platinum dRF may also be used for outpatient or emergency services, as well as for mobile transport examinations (wheelchair and bed). The Platinum dRF is not indicated for use in interventional radiology.

Source page: https://510kreport.com/device/K203010
Methodology: https://510kreport.com/methodology