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FDA 510(k)

OMNIDOS

K-Number: K011763 · 2001-09-05

ApplicantScanditronix Medical AB
Decision Date2001-09-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNIDOS is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix Medical AB. It received FDA 510(k) clearance on 2001-09-05 under 510(k) number K011763. 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 OMNIDOS?

OMNIDOS is a medical device that received FDA 510(k) clearance on 2001-09-05. The listed applicant is Scanditronix Medical AB. The 510(k) number is K011763.

When did OMNIDOS receive FDA 510(k) clearance?

OMNIDOS received FDA 510(k) clearance on 2001-09-05, under 510(k) number K011763.

Who is the listed applicant for OMNIDOS?

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

What is the FDA product code for OMNIDOS?

The FDA product code for OMNIDOS 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

Other records listing Scanditronix Medical 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.

K002051INVIDOSK990734DPD-12PCCK961400RFA-300, LDA UTILITY

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.

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