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FDA 510(k)

ControlRad Trace Model 8

K-Number: K183109 · 2019-05-13

ApplicantControlrad, Inc.
Decision Date2019-05-13
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ControlRad Trace Model 8 is the device name listed in this FDA 510(k) record. The listed applicant is Controlrad, Inc.. It received FDA 510(k) clearance on 2019-05-13 under 510(k) number K183109. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ControlRad Trace Model 8?

ControlRad Trace Model 8 is a medical device that received FDA 510(k) clearance on 2019-05-13. The listed applicant is Controlrad, Inc.. The 510(k) number is K183109.

When did ControlRad Trace Model 8 receive FDA 510(k) clearance?

ControlRad Trace Model 8 received FDA 510(k) clearance on 2019-05-13, under 510(k) number K183109.

Who is the listed applicant for ControlRad Trace Model 8?

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

What is the FDA product code for ControlRad Trace Model 8?

The FDA product code for ControlRad Trace Model 8 is OWB.

Other records listing Controlrad, 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.

K213455ControlRad Select Model ZK211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9K202431ControlRad Select Model ZK200663ControlRad Trace Model 9K200238ControlRad Sterile Cover

Related Devices (Code: OWB)

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.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

Official Source

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

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