Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ORTHO H FILM

K-Number: K771681 · 1977-09-14

ApplicantEastman Kodak Company
Decision Date1977-09-14
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ORTHO H FILM is the device name listed in this FDA 510(k) record. The listed applicant is Eastman Kodak Company. It received FDA 510(k) clearance on 1977-09-14 under 510(k) number K771681. 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 ORTHO H FILM?

ORTHO H FILM is a medical device that received FDA 510(k) clearance on 1977-09-14. The listed applicant is Eastman Kodak Company. The 510(k) number is K771681.

When did ORTHO H FILM receive FDA 510(k) clearance?

ORTHO H FILM received FDA 510(k) clearance on 1977-09-14, under 510(k) number K771681.

Who is the listed applicant for ORTHO H FILM?

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

What is the FDA product code for ORTHO H FILM?

The FDA product code for ORTHO H FILM is IWZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Eastman Kodak Company 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.

K060550KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386K060137KODAK ECLIPSE IMAGE PROCESSING SOFTWAREK060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEMK060055KODAK PACSK053347KODAK CARESTREAM PACSK051483KODAK DIRECTVIEW DR SYSTEM DETECTOR

View all 238 devices →

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.

↑