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)

COMPASS

K-Number: K072374 · 2007-12-07

ApplicantScanditronix Wellhofer GmbH
Decision Date2007-12-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPASS is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix Wellhofer GmbH. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K072374. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPASS?

COMPASS is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Scanditronix Wellhofer GmbH. The 510(k) number is K072374.

When did COMPASS receive FDA 510(k) clearance?

COMPASS received FDA 510(k) clearance on 2007-12-07, under 510(k) number K072374.

Who is the listed applicant for COMPASS?

The FDA 510(k) record lists Scanditronix Wellhofer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPASS?

The FDA product code for COMPASS is IYE.

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

Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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.

↑