Radiology · 510(k) · 2020
TOMTEC-ARENA
TOMTEC Imaging Systems GmbH. Cleared by FDA on 14 August 2020 under submission K201632, product code LLZ (system, image processing, radiological). What FDA's record says, in FDA's words.
Device record · K201632
- Device. TOMTEC-ARENADEVICE
- Company. TOMTEC Imaging Systems GmbH (DE)COMPANY
- Decision. 14 August 2020, 510(k), substantially equivalent (traditional review); received 16 June 2020DECISION
- Panel. RadiologyPANEL
- Product code. LLZ, System, Image Processing, RadiologicalCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (14 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.
of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physicians in the diagnosis. 4) DEVICE DESCRIPTION TOMTEC-ARENA (TTA2) is a clinical software package for reviewing, quantifying and reporting digital medical data. The software is compatible with different IMAGE-ARENA platforms and third party platforms. Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes. TTA2 consists of the following optional modules: K201632 510(k) Summary TOMTEC-ARENA (TTA2.40) TOMTEC Imaging Systems GmbH Confidential TOMTEC-ARENA SERVER & CLIENT IMAGE-COM/ECHO-COM REPORTING AutoStrain (LV, LA, RV) 2D CARDIAC-PERFORMANCE ANALYSIS (Adult and Fetal) 4D LV-ANALYSIS 4D RV-FUNCTION 4D CARDIO-VIEW 4D MV-ASSESSMENT 4D SONO-SCAN 5) SUBSTANTIALLY EQUIVALENT DEVICES Primary Predicate Device: TomTec-Arena TTA2 K150122 (February 13, 2015) Secondary Predicate Device: QLAB Advanced Quantification Software K200974 (June 03, 2020) TOMTEC Imaging Systems GmbH believes that the TOMTEC-ARENA modifications that are the subject of this 510(k) are substantially equivalent to TomTec-Arena TTA2 (K150122). 6) TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES The TOMTEC-ARENA software with the modifi ed modules […]
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.
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 19,970 reports filed against devices carrying product code LLZ. 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:
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101631
Philips received a complaint on the IntelliSpace Cardiovascular (ISCV) indicating that the ISCV could only be accessed in Web-Only mode on the workstation. The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint ((b)(4)).Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101632
Philips received a complaint on the IntelliSearch Cardiovascular (ISCV) indicating that customer reported that study retrieval from the archive was either failing or taking an excessively long time to complete. The device was in clinical use at the time of the event, and no adverse events or harm were reported in the complaint (b)(4).Philips has started an investigation of this complaint.
30 September 2026 · Malfunction · IntelliSpace CardioVascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101634
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user was reported that DICOM import crashed occasionally as there was a PDFClinicalContentExecuter error.. The device was in clinical use at the time of event.Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on […]
30 September 2026 · Malfunction · IntelliSpace CardioVascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101635
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein the user could not save the findings. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it were to recur, it is determined that this […]
30 September 2026 · Malfunction · IntelliSpace Cardiovascular · Philips Medical Systems Nederland B.V. · report 3003768277-2026-101636
Philips identified a software defect in ISCV (IntelliSpace Cardiovascular) system wherein user reported that it was not possible to view previous studies in Echo Module. The device was in clinical use at the time of event. Based on the new information that Philips became aware, this has been determined to be a reportable malfunction. Under specific circumstances, it could potentially lead to delayed diagnosis. Given the defect¿s nature and its potential impact on clinical decision-making if it […]
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 LLZ, in Radiology, from TOMTEC Imaging Systems GmbH, or cleared in 2020. 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.