# K990248: Dicom Image Manager, Model 3-D Visualization Option

- Pathway: 510(k) (Traditional)
- Applicant: Dicomit Imaging Systems Corp.
- Decided: Apr 16, 1999 after 80 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930768 (1994). 4 ancestors in all.
213 later devices descend from it; 1 cites it directly.
0 of 218 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951925: Dicomit, Dicomit Imaging Systems Corp. (1995) Summary page 1.
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1.
- K964617: GE Logiq 700 Diagnostic Ultrasound System, GE Medical Systems (1997) Summary page 1.

## Most influential descendants
- K992886: Powerview Ultrasound Workstation, Uidm-400A (1999), 212 descendants of its own
- K013633: Ssa-770A, Aplio Ultrasound System (2001), 211 descendants of its own
- K022400: Ssa-700A, Aplio Diagnostic Ultrasound System (2002), 210 descendants of its own
- K032281: Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System (2003), 209 descendants of its own
- K063130: Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 (2006), 205 descendants of its own

## Indications for use
The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation. The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.

Source page: https://510kreport.com/device/K990248
Methodology: https://510kreport.com/methodology