FDA 510(k)

ND1100 BONE DENSITY SCANNER

K-Number: K844766 · 1985-04-16

Decision Date1985-04-16

Product CodeKGI

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ND1100 BONE DENSITY SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Data, Inc.. It received FDA 510(k) clearance on 1985-04-16 under 510(k) number K844766. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ND1100 BONE DENSITY SCANNER?

ND1100 BONE DENSITY SCANNER is a medical device that received FDA 510(k) clearance on 1985-04-16. The listed applicant is Nuclear Data, Inc.. The 510(k) number is K844766.

When did ND1100 BONE DENSITY SCANNER receive FDA 510(k) clearance?

ND1100 BONE DENSITY SCANNER received FDA 510(k) clearance on 1985-04-16, under 510(k) number K844766.

Who is the listed applicant for ND1100 BONE DENSITY SCANNER?

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

What is the FDA product code for ND1100 BONE DENSITY SCANNER?

The FDA product code for ND1100 BONE DENSITY SCANNER is KGI.

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Other records listing Nuclear Data, Inc. as applicant

K891466ACCUSPEC THYROID UPTAKE SYSTEM K881383ND1100 BONE DENSITY SCANNER K844835ND2100 SPINE SCANNER K843349ND3100 VIDEO IMAGER K841440ND62T THYROID UPTAKE SYSTEM K841352ND1200 RIA COUNTER

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Related Devices (Code: KGI)

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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.