# K092581: Mits Dicom Gateway and Image Manager

- Pathway: 510(k) (Traditional)
- Applicant: Mitsmed Medical Instrument Technology Co., Ltd.
- Decided: Oct 30, 2009 after 70 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922164 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012327: Csist Dicom Gateway/Image Manager, Csist (2001) Summary page 1.

## Indications for use
The MITS DICOM Gateway and Image Manager is a device that captures 2 dimensional images and data or receives images and data from various medical imaging sources ( i.e. ultrasound System, R/F units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data (2 dimensional or 3 dimensional) can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals. To support the diagnostic interpretation of mammography studies the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film Screen images must not be reviewed for primary diagnosis or image interpretation.

Source page: https://510kreport.com/device/K092581
Methodology: https://510kreport.com/methodology