# K963628: Imageshare Computed Radiography Acquisition Station and/or Software

- Pathway: 510(k) (Traditional)
- Applicant: Dejarnette Research Systems
- Decided: Nov 7, 1996 after 57 days
- Product code: LMD (System, Digital Image Communications, Radiological)
- Device class: 1
- Regulation: 21 CFR 892.2020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Imageshare 910: named in the summary without a submission number
- (no number) Fuji Computed Radiography DMS CRT Image Console HI-C654™: named in the summary without a submission number
- (no number) CEMAX ScanLink IVIM QA Station: named in the summary without a submission number
- (no number) Analogic SD100 CR Gateway: named in the summary without a submission number

## Most influential descendants
- K980213: DI-2000 (1998), 5 descendants of its own
- K020243: Laserpro 16 (2002), 3 descendants of its own
- K052938: CR-PRO (2005), 2 descendants of its own
- K142718: Radlink GPS (2014), 1 descendant of its own
- K242161: Radlink GPS Pro Imaging (2025), 0 descendants of its own

## Indications for use
The Imageshare Computed Radiography Acquisition Station and/or Software is a uni-directional gateway that receives digital images from various image sources (including, but not limited to, Fuji CR, Fuji HI-C654, Analogic Corporation’s DASM, Computed Radiography or Direct Radiography devices). The incoming data formats may be raw CR data, processed CR data or data formats proprietary to the modality source vendor. The Imageshare Computed Radiography Acquisition Station and/or Software converts the data to DICOM, ACR-NEMA v2.0, SPI format or other proprietary data format and transmits the data to one or more user-specified nodes across a standard, general purpose computing network.

Source page: https://510kreport.com/device/K963628
Methodology: https://510kreport.com/methodology