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FDA 510(k)

DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM

K-Number: K852353 · 1985-08-07

ApplicantThomson-Cgr Medical Corp.
Decision Date1985-08-07
Product CodeIXI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Thomson-Cgr Medical Corp.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K852353. The device is classified under product code IXI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM?

DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Thomson-Cgr Medical Corp.. The 510(k) number is K852353.

When did DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM receive FDA 510(k) clearance?

DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM received FDA 510(k) clearance on 1985-08-07, under 510(k) number K852353.

Who is the listed applicant for DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM?

The FDA 510(k) record lists Thomson-Cgr Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM?

The FDA product code for DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM is IXI.

Related Clinical Trials

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Other records listing Thomson-Cgr Medical 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.

K873618STEREOTIXK873544MPG-50 X-RAY GENERATOR

Related Devices (Code: IXI)

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.

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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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