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FDA 510(k)

TRANS X-1000

K-Number: K945635 · 1995-02-01

ApplicantCanon USA, Inc.
Decision Date1995-02-01
Product CodeKPX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANS X-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Canon USA, Inc.. It received FDA 510(k) clearance on 1995-02-01 under 510(k) number K945635. The device is classified under product code KPX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS X-1000?

TRANS X-1000 is a medical device that received FDA 510(k) clearance on 1995-02-01. The listed applicant is Canon USA, Inc.. The 510(k) number is K945635.

When did TRANS X-1000 receive FDA 510(k) clearance?

TRANS X-1000 received FDA 510(k) clearance on 1995-02-01, under 510(k) number K945635.

Who is the listed applicant for TRANS X-1000?

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

What is the FDA product code for TRANS X-1000?

The FDA product code for TRANS X-1000 is KPX.

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Other records listing Canon USA, 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.

K090623DIGITAL RADIOGRAPHY CXDI-40G COMPACTK033624PACS SOFTWARE SOLUTION 2003K031633CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40CK031629CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGIK023750CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40GK023586DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS

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Related Devices (Code: KPX)

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.

K935157ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESRegulatory Consultants TO the Medical Device IndusK934850NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDSVictoreen, Inc.K933035BCM-600TXB C Medical , Ltd.K925598BUCKYMATIC AUTOMATIC CHEST FILM CHANGERAcoma Medical Imaging, Inc.K924423MWX-7440 HIGH SPEED BUCKYMidwest X-Ray Equipment Co.K925169SHIMADZU RADIOGRAPJHIC STAND BR-100Shimadzu Medical Systems

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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