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FDA 510(k)

NDI MODEL IRS-TD

K-Number: K904676 · 1991-06-21

ApplicantNational Diagnostic Imaging, Inc.
Decision Date1991-06-21
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NDI MODEL IRS-TD is the device name listed in this FDA 510(k) record. The listed applicant is National Diagnostic Imaging, Inc.. It received FDA 510(k) clearance on 1991-06-21 under 510(k) number K904676. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NDI MODEL IRS-TD?

NDI MODEL IRS-TD is a medical device that received FDA 510(k) clearance on 1991-06-21. The listed applicant is National Diagnostic Imaging, Inc.. The 510(k) number is K904676.

When did NDI MODEL IRS-TD receive FDA 510(k) clearance?

NDI MODEL IRS-TD received FDA 510(k) clearance on 1991-06-21, under 510(k) number K904676.

Who is the listed applicant for NDI MODEL IRS-TD?

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

What is the FDA product code for NDI MODEL IRS-TD?

The FDA product code for NDI MODEL IRS-TD is KPR.

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Related Devices (Code: KPR)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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