Radiology · 510(k) · 2022
syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.. Cleared by FDA on 17 May 2022 under submission K221219, product code JAK (system, x-ray, tomography, computed). What FDA's record says, in FDA's words.
Device record · K221219
- Device. syngo.CT CaScoringDEVICE
- Company. Siemens Medical Solutions USA, Inc.COMPANY
- Decision. 17 May 2022, 510(k), substantially equivalent (special review); received 27 April 2022DECISION
- Panel. RadiologyPANEL
- Product code. JAK, System, X-Ray, Tomography, ComputedCODE
- Regulation. 21 CFR 892.1750, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets. The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user- documented images, cited literature and additional relevant information. K221219 -510(k) Summary 2 of 5
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT
- Mentionsmeasurement or quantification
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 5,281 reports filed against devices carrying product code JAK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
25 September 2026 · Malfunction · REVOLUTION EVO · GE MEDICAL SYSTEMS, LLC · report 50896044
The GE CT table wouldn't move during stroke. Patient had to be physically moved to resume scan, delay in care. GE CT table has had the same issues with the table working intermittently x 3 weeks. Multiple techs have worked on it and the same problem persists.
25 September 2026 · Malfunction · Needle Guide · Quantum Surgical SAS · report 3023140882-2026-00002
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00087
It was reported that during the procedure, one locatable guide indicated as outside of the sensor sensing volume and another locatable guide had difficulty retracting from the extended working channel. The physician completed the superDimension portion of the case. No patient complications have been reported as a result of this event.
23 September 2026 · Other · NL4000 · Samsung HME America, Inc. · report 3004938766-2026-00043
23 September 2026 · Malfunction · ILLUMISITE · COVIDIEN LP - SUPERDIMENSION INC · report 3004962788-2026-00088
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JAK, in Radiology, from Siemens Medical Solutions USA, Inc., or cleared in 2022. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.