DeviceClearance

CONTRAST ENHANCED DIGITAL MAMMOGRAPHY— 510(k) K123873

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K123873 for CONTRAST ENHANCED DIGITAL MAMMOGRAPHY, Substantially Equivalent on 2013-01-29. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant
Hologic, Inc.
Product code
Code MUE
Device class
Class 2
Regulation
21 CFR 892.1715
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bedford, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MUE

product code MUE
Death
5
Other
1
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K123873

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123873.

Data sourced from openFDA. This site is unofficial and independent of the FDA.