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FDA 510(k)

DILON 6800 ACELLA (ACELLA)

K-Number: K110384 · 2011-05-03

ApplicantDilon Technologies, Inc.
Decision Date2011-05-03
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DILON 6800 ACELLA (ACELLA) is the device name listed in this FDA 510(k) record. The listed applicant is Dilon Technologies, Inc.. It received FDA 510(k) clearance on 2011-05-03 under 510(k) number K110384. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DILON 6800 ACELLA (ACELLA)?

DILON 6800 ACELLA (ACELLA) is a medical device that received FDA 510(k) clearance on 2011-05-03. The listed applicant is Dilon Technologies, Inc.. The 510(k) number is K110384.

When did DILON 6800 ACELLA (ACELLA) receive FDA 510(k) clearance?

DILON 6800 ACELLA (ACELLA) received FDA 510(k) clearance on 2011-05-03, under 510(k) number K110384.

Who is the listed applicant for DILON 6800 ACELLA (ACELLA)?

The FDA 510(k) record lists Dilon Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DILON 6800 ACELLA (ACELLA)?

The FDA product code for DILON 6800 ACELLA (ACELLA) is IYX.

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 Dilon Technologies, Inc. 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.

K984466DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5

Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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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