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FDA 510(k)

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER

K-Number: K033224 · 2003-11-05

ApplicantHologic, Inc.
Decision Date2003-11-05
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2003-11-05 under 510(k) number K033224. 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 HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER?

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER is a medical device that received FDA 510(k) clearance on 2003-11-05. The listed applicant is Hologic, Inc.. The 510(k) number is K033224.

When did HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER receive FDA 510(k) clearance?

HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER received FDA 510(k) clearance on 2003-11-05, under 510(k) number K033224.

Who is the listed applicant for HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER?

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

What is the FDA product code for HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER?

The FDA product code for HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER is KGI.

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Other records listing Hologic, Inc. as applicant

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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.

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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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