# K102327: Clearvision DR 7000F

- Pathway: 510(k) (Traditional)
- Applicant: Jpi Healthcare Co, Ltd.
- Decided: Apr 13, 2012 after 605 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: 5 generations back to K862120 (1986). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083640: Digital X-Ray Imaging System, Model: CXD-DR80D, Choong Wae Medical Corp. (2009) Summary page 1.
- K090742: Digital Flat Panel X-Ray Detector, Model LTX240AA01-a, Samsung Mobile Display Co., Ltd. (2009) Summary page 1.
- K102587: LLX240AB01, Samsung Mobile Display Co., Ltd. (2010). Cleared while this submission was under review Summary page 1.

## Indications for use
The Clear Vision DR7000F product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,. chest, abdomen, extremities, and other body parts. Applications can be performned with the patient sifting, standing, or lying in the prone or supine position. The Clear Vision DR7000F system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.

Source page: https://510kreport.com/device/K102327
Methodology: https://510kreport.com/methodology