# K973421: Imageshare Computed Radiography Acquisition Station and/or Software (2100{Sikarus X86}/(1500{Windows NT}

- Pathway: 510(k) (Traditional)
- Applicant: Dejarnette Research Systems
- Decided: Dec 5, 1997 after 86 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Computed Radiography Acquisition Station and/or Software: named in the summary without a submission number

## Indications for use
The Imageshare Computed Radiography Acquisition Station and/or Software is a bi-directional gateway that sends or receives digital images to/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/K973421
Methodology: https://510kreport.com/methodology