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FDA 510(k)

GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)

K-Number: K901857 · 1990-07-09

ApplicantAmersham Corp.
Decision Date1990-07-09
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1990-07-09 under 510(k) number K901857. 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 GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)?

GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) is a medical device that received FDA 510(k) clearance on 1990-07-09. The listed applicant is Amersham Corp.. The 510(k) number is K901857.

When did GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) receive FDA 510(k) clearance?

GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) received FDA 510(k) clearance on 1990-07-09, under 510(k) number K901857.

Who is the listed applicant for GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)?

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

What is the FDA product code for GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)?

The FDA product code for GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) is KGI.

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Other records listing Amersham 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

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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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