# K972903: Imatron Ultra Access Workstation with Cardiac Software Extensions

- Pathway: 510(k) (Traditional)
- Applicant: Imatron, Inc.
- Decided: Nov 4, 1997 after 90 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
353 later devices descend from it; 5 cite it directly.
1 of 354 devices in its family (counting itself) has 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) C150XP’s Physician Workstation: named in the summary without a submission number
- (no number) NetraMD Workstation: named in the summary without a submission number
- (no number) AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation: named in the summary without a submission number
- (no number) VRSAPP Workstation: named in the summary without a submission number

## Most influential descendants
- K012086: Aquariusnet Server (2001), 207 descendants of its own
- K990426: Calcium Scoring (1999), 166 descendants of its own
- K061214: Aquariusaps Server (2006), 134 descendants of its own
- K043111: Plaqueview Software, Model CSPV-0001A (2004), 112 descendants of its own
- K061624: Vitrea, Version 3.9 (2006), 111 descendants of its own

## Indications for use
The Imatron Ultra Access Workstation is intended as an accessory to Imatron’s Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron’s Ultrafast CT scanner and allows for advanced post processing of such data. Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices — for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.

Source page: https://510kreport.com/device/K972903
Methodology: https://510kreport.com/methodology