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FDA 510(k)

TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM

K-Number: K862415 · 1986-07-01

ApplicantParexel Intl. Corp.
Decision Date1986-07-01
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1986-07-01 under 510(k) number K862415. The device is classified under product code IWZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM?

TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM is a medical device that received FDA 510(k) clearance on 1986-07-01. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K862415.

When did TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM receive FDA 510(k) clearance?

TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM received FDA 510(k) clearance on 1986-07-01, under 510(k) number K862415.

Who is the listed applicant for TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM?

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

What is the FDA product code for TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM?

The FDA product code for TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM is IWZ.

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Other records listing Parexel Intl. 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.

K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGEK904901L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUCK904902SMA 26 TRANSDUCERK884800ACTA GENOS ELECTROCARDIOGRAPHK862414FUJI CR IMAGING PLATEK864519PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)

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Related Devices (Code: IWZ)

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.

K970154KODAK EKTASIAN HG FILM (EHG-15)Eastman Kodak CompanyK954200VOXGRAMVoxelK9316043M MEDICAL DIAGNOSTIC VIDEOCASSETTE3M Health Care, Ltd.K9316053M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE3M Health Care, Ltd.K920539ORWO X-RAY FILMBurkhart Roentgen Intl., Inc.K884827KODAK DENTAL BARRIER PACEastman Kodak Company

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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