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FDA 510(k)

3.0T PROSTATE IMAGING SYSTEM

K-Number: K051349 · 2005-06-23

ApplicantMedrad, Inc.
Decision Date2005-06-23
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3.0T PROSTATE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2005-06-23 under 510(k) number K051349. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.0T PROSTATE IMAGING SYSTEM?

3.0T PROSTATE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-23. The listed applicant is Medrad, Inc.. The 510(k) number is K051349.

When did 3.0T PROSTATE IMAGING SYSTEM receive FDA 510(k) clearance?

3.0T PROSTATE IMAGING SYSTEM received FDA 510(k) clearance on 2005-06-23, under 510(k) number K051349.

Who is the listed applicant for 3.0T PROSTATE IMAGING SYSTEM?

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

What is the FDA product code for 3.0T PROSTATE IMAGING SYSTEM?

The FDA product code for 3.0T PROSTATE IMAGING SYSTEM is MOS.

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Other records listing Medrad, 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.

K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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Related Devices (Code: MOS)

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.

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLCK252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.

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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