# K982319: Caregraph

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 22, 1998 after 82 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K853753 (1985). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853753: Diamentor Patient X-Ray Exposure Indicator 07302, Victoreen, Inc. (1985) Summary page 1.
- (no number) Diamentor M1/M2/M3: named in the summary without a submission number

## Most influential descendants
- K123097: Dose Tracking System Model Xidf-DTS801 (2013), 9 descendants of its own
- K132106: Infinix Angio Workstation W/DTS Software (2013), 8 descendants of its own
- K141541: Xidf-AWS801, Angio Workstation, V5.31 (2014), 7 descendants of its own
- K142736: XIDF-AWS801, Angio Workstation, v5.31 (2015), 6 descendants of its own
- K150967: XIDF-AWS801, Angio Workstation, V6.10 (2015), 5 descendants of its own

## Indications for use
CAREGRAPH is an angiographic system accessory for recording, displaying and documenting the regional distribution of the skin entry dose of a patient, depending on the relevant angulations in X-ray examination. The dose is calculated depending on the format size, the angulation and the table position and displayed on a graphical patient body surface.

Source page: https://510kreport.com/device/K982319
Methodology: https://510kreport.com/methodology