# K962613: Darpac 2000 Superficial X-Ray Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Gulmay Medical, Ltd.
- Decided: Sep 27, 1996 after 86 days
- Product code: JAD (System, Therapeutic, X-Ray)
- Device class: 2
- Regulation: 21 CFR 892.5900
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K063456: SRT100 Superficial Radiation Therapy System (2007), 9 descendants of its own
- K123985: Sensus Healthcare Superficial Radiotherapy System SRT-100 (2013), 7 descendants of its own
- K131582: Sensus Helthcare Image-Duided Superficial Radiotherapy System (2013), 4 descendants of its own
- K150037: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (2015), 3 descendants of its own
- K172080: Photoelectric Therapy System (2017), 1 descendant of its own

## Recalls of this device
- Aug 27, 2021 · Class II · Z-0389-2022: Base plate may detach from the main body of the treatment applicator.
- Apr 26, 2021 · Class II · Z-0174-2022: If a saved treatment plan with 2 opposing beams is edited prior to approval, then Beam 2 is not updated with the changed parameters upon selecting save, resulting in error messages during the treatmen

Source page: https://510kreport.com/device/K962613
Methodology: https://510kreport.com/methodology