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FDA 510(k)

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER

K-Number: K101038 · 2010-08-17

ApplicantAcceletronics Digital Imaging, LLC
Decision Date2010-08-17
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER is the device name listed in this FDA 510(k) record. The listed applicant is Acceletronics Digital Imaging, LLC. It received FDA 510(k) clearance on 2010-08-17 under 510(k) number K101038. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER?

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER is a medical device that received FDA 510(k) clearance on 2010-08-17. The listed applicant is Acceletronics Digital Imaging, LLC. The 510(k) number is K101038.

When did RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER receive FDA 510(k) clearance?

RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER received FDA 510(k) clearance on 2010-08-17, under 510(k) number K101038.

Who is the listed applicant for RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER?

The FDA 510(k) record lists Acceletronics Digital Imaging, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER?

The FDA product code for RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER is KPQ.

Related Clinical Trials

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Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLCK052361SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAMNucletron Corporation

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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