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FDA 510(k)

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)

K-Number: K901854 · 1990-07-09

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

Device Summary

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) 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 K901854. 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.10411/10412)?

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) 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 K901854.

When did GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) receive FDA 510(k) clearance?

GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) received FDA 510(k) clearance on 1990-07-09, under 510(k) number K901854.

Who is the listed applicant for GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)?

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.10411/10412)?

The FDA product code for GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) 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 SERAK901857GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)

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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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