# K023292: Apex Hri Digital Radiography System

- Pathway: 510(k) (Traditional)
- Applicant: Krugman Technologies, Inc.
- Decided: Dec 13, 2002 after 72 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933455 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950532: Trophy Radiologie RVG Portable Radiovisiography, Trophy Radiologie (1995) Summary page 1.
- K002425: Mediadent HDX/MMD HDX SP Xray Sensor, Multi Media Dental Systems, Inc. (2000)
- K933455: Computed Oral Radiology System, Schick Technologies, Inc. (1994) Summary page 1.

## Indications for use
The Apex HRI Digital Radiography System is designed to replace standard intraoral x-ray film and film development chemicals used for patient diagnostics in dental practices. The Apex HRI Digital Xray Sensor is covered with a sterile disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray. The dental x-ray tube (which is NOT part of this product) is pointed at the sensor and activated. The emitted radiation from the x-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. The imaging software interprets the data stream and displays it as a grey scale image on the monitor of the connected computer system. The grey scale image is the digitally formed x-ray the dentist will then use for diagnostics.

Source page: https://510kreport.com/device/K023292
Methodology: https://510kreport.com/methodology