510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023398Substantially Equivalent

Hologic Qdr X-Ray Bone Densitometer, Models 1000, 2000, 4500, Delphi, Discovery

Hologic, Inc., Bedford MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023398 is the FDA 510(k) clearance record for HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY, a class II device, cleared for Hologic, Inc. on under FDA product code KGI (Densitometer, Bone). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show one recall naming K023398.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Hologic, Inc. 35 Crosby Dr., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260