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FDA 510(k)

IREX REAL TIME PHASED ARRAY SYSTEM

K-Number: K791317 · 1979-09-17

ApplicantIrex Corp.
Decision Date1979-09-17
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IREX REAL TIME PHASED ARRAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Irex Corp.. It received FDA 510(k) clearance on 1979-09-17 under 510(k) number K791317. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IREX REAL TIME PHASED ARRAY SYSTEM?

IREX REAL TIME PHASED ARRAY SYSTEM is a medical device that received FDA 510(k) clearance on 1979-09-17. The listed applicant is Irex Corp.. The 510(k) number is K791317.

When did IREX REAL TIME PHASED ARRAY SYSTEM receive FDA 510(k) clearance?

IREX REAL TIME PHASED ARRAY SYSTEM received FDA 510(k) clearance on 1979-09-17, under 510(k) number K791317.

Who is the listed applicant for IREX REAL TIME PHASED ARRAY SYSTEM?

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 REAL TIME PHASED ARRAY SYSTEM?

The FDA product code for IREX REAL TIME PHASED ARRAY SYSTEM is CDP.

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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 SCANNERK840139IREX 720 SECTOR SCANNERK827370IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEMK813544IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS.

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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