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FDA 510(k)

IREX 720 SECTOR SCANNER

K-Number: K840139 · 1984-05-09

ApplicantIrex Corp.
Decision Date1984-05-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IREX 720 SECTOR SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K840139. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IREX 720 SECTOR SCANNER?

IREX 720 SECTOR SCANNER is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Irex Corp.. The 510(k) number is K840139.

When did IREX 720 SECTOR SCANNER receive FDA 510(k) clearance?

IREX 720 SECTOR SCANNER received FDA 510(k) clearance on 1984-05-09, under 510(k) number K840139.

Who is the listed applicant for IREX 720 SECTOR SCANNER?

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

What is the FDA product code for IREX 720 SECTOR SCANNER?

The FDA product code for IREX 720 SECTOR SCANNER is IYO.

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Other records listing Irex Corp. 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.

K844404IREX PS, PORTABLE SCANNER AND 118K843643COLOR DOPPLER 880K842408IREX 730 MECHANICAL SECTOR SCANNERK827370IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEMK813544IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.K811246DOPPLER ULTRASOUND BLOOD FLOWMETER

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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