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FDA 510(k)

ND2100 SPINE SCANNER

K-Number: K844835 · 1985-04-18

ApplicantNuclear Data, Inc.
Decision Date1985-04-18
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ND2100 SPINE 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 1985-04-18 under 510(k) number K844835. 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 ND2100 SPINE SCANNER?

ND2100 SPINE SCANNER is a medical device that received FDA 510(k) clearance on 1985-04-18. The listed applicant is Nuclear Data, Inc.. The 510(k) number is K844835.

When did ND2100 SPINE SCANNER receive FDA 510(k) clearance?

ND2100 SPINE SCANNER received FDA 510(k) clearance on 1985-04-18, under 510(k) number K844835.

Who is the listed applicant for ND2100 SPINE 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 ND2100 SPINE SCANNER?

The FDA product code for ND2100 SPINE SCANNER is KGI.

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Other records listing Nuclear Data, 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.

K891466ACCUSPEC THYROID UPTAKE SYSTEMK881383ND1100 BONE DENSITY SCANNERK844766ND1100 BONE DENSITY SCANNERK843349ND3100 VIDEO IMAGERK841440ND62T THYROID UPTAKE SYSTEMK841352ND1200 RIA COUNTER

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Related Devices (Code: KGI)

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.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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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