510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K871553Substantially Equivalent

X-Caliber Model 1000 Bone Mineral Analyzer

Hologic, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871553 is the FDA 510(k) clearance record for X-CALIBER MODEL 1000 BONE MINERAL ANALYZER, 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 no recalls naming K871553.

Clearance record

Decision date
Received
(169 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Hologic, Inc. 590 Lincoln St., Waltham MA
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