# K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System

- Pathway: 510(k) (Traditional)
- Applicant: Medicatech USA
- Decided: Nov 18, 2011 after 115 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- 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: 7 generations back to K896095 (1990). 26 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080582: Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA, Medicatech USA (2008) Summary page 1.
- K110040: Omnivision, Modern Module, Inc. (2011) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 1.

## Most influential descendants
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T (2013), 11 descendants of its own
- K140825: Delworks DR System (2014), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own
- K192541: DigiX FDX (2019), 5 descendants of its own
- K223060: DigiX FDX (2022), 4 descendants of its own

## Indications for use
Intended for use by a qualified/trained doctor or technologist. As part of a radiographic system, the KrystalRad 660 is intended to acquire digital radiographic images. It is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

Source page: https://510kreport.com/device/K112132
Methodology: https://510kreport.com/methodology