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)

COBRASCAN CX-312

K-Number: K953942 · 1995-12-22

Decision Date1995-12-22
Product CodeLMA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COBRASCAN CX-312 is the device name listed in this FDA 510(k) record. The listed applicant is Radiographic Digital Imaging, Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K953942. The device is classified under product code LMA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBRASCAN CX-312?

COBRASCAN CX-312 is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Radiographic Digital Imaging, Inc.. The 510(k) number is K953942.

When did COBRASCAN CX-312 receive FDA 510(k) clearance?

COBRASCAN CX-312 received FDA 510(k) clearance on 1995-12-22, under 510(k) number K953942.

Who is the listed applicant for COBRASCAN CX-312?

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

What is the FDA product code for COBRASCAN CX-312?

The FDA product code for COBRASCAN CX-312 is LMA.

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.

Other records listing Radiographic Digital Imaging, 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.

Related Devices (Code: LMA)

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.

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.

↑