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)

JPI X-RAY FILM CASSETTE

K-Number: K945328 · 1995-01-20

ApplicantJpi America, Inc.
Decision Date1995-01-20
Product CodeIXA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JPI X-RAY FILM CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Jpi America, Inc.. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K945328. The device is classified under product code IXA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JPI X-RAY FILM CASSETTE?

JPI X-RAY FILM CASSETTE is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Jpi America, Inc.. The 510(k) number is K945328.

When did JPI X-RAY FILM CASSETTE receive FDA 510(k) clearance?

JPI X-RAY FILM CASSETTE received FDA 510(k) clearance on 1995-01-20, under 510(k) number K945328.

Who is the listed applicant for JPI X-RAY FILM CASSETTE?

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

What is the FDA product code for JPI X-RAY FILM CASSETTE?

The FDA product code for JPI X-RAY FILM CASSETTE is IXA.

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 Jpi America, 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.

K052341AJEX 9015/135H PORTABLE X-RAYK945327JPI X-RAY GRID

Related Devices (Code: IXA)

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.

K081557PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDERJddb Manufacturing, Inc.K053173DS CASSETTEKonica Minolta Medical & Graphic, Inc.K040378KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253Eastman Kodak CompanyK023020AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTEAgfa Corp.K021903KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USEEastman Kodak CompanyK013686KODAK DIRECTVIEW TABLETOP CASSETTEEastman 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.

↑