# K041213: 3DSCOPE

- Pathway: 510(k) (Special)
- Applicant: Direx Systems Corp.
- Decided: Jul 22, 2004 after 73 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- 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: 1 generation back to K965013 (1997). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965013: Digiscope RX-2 (9 Option), Medirex, Inc. (1997). Our OCR of the scanned summary read K865013, FDA’s number for Astra T2, T4 and T6 (Cardiac Pacemakers, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Digiscope RX-2 (9" option)”.

## Most influential descendants
- K053640: Integra (2006), 6 descendants of its own
- K062147: Integra SL (2006), 3 descendants of its own
- K072538: Piezolith 3000 Triple-Focus Lithotripter (2008), 2 descendants of its own
- K252913: Break Wave (2026), 1 descendant of its own
- K052212: MIGUE (2006), 1 descendant of its own

## Indications for use
The 3Dscope is a mobile apparatus used for flucroscopic examination of a patient.

Source page: https://510kreport.com/device/K041213
Methodology: https://510kreport.com/methodology