Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRS 2000 TELERADIOLOGY SYSTEM

K-Number: K961983 · 1996-08-13

ApplicantSectra-Imtec AB
Decision Date1996-08-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRS 2000 TELERADIOLOGY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sectra-Imtec AB. It received FDA 510(k) clearance on 1996-08-13 under 510(k) number K961983. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRS 2000 TELERADIOLOGY SYSTEM?

TRS 2000 TELERADIOLOGY SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-13. The listed applicant is Sectra-Imtec AB. The 510(k) number is K961983.

When did TRS 2000 TELERADIOLOGY SYSTEM receive FDA 510(k) clearance?

TRS 2000 TELERADIOLOGY SYSTEM received FDA 510(k) clearance on 1996-08-13, under 510(k) number K961983.

Who is the listed applicant for TRS 2000 TELERADIOLOGY SYSTEM?

The FDA 510(k) record lists Sectra-Imtec AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRS 2000 TELERADIOLOGY SYSTEM?

The FDA product code for TRS 2000 TELERADIOLOGY SYSTEM is LLZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sectra-Imtec AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110025SECTRA MICRODOSE MAMMOGRAPHYK081469SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2K063093SECTRA WORKSTATION, VERSION 11.1K051315MODIFICATION TO: SECTRA IDS5 WORKSTATIONK050196SECTRA IDS5 WORKSTATIONK040376SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE

View all 14 devices →

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑