DeviceClearance

CARESTREAM IMAGE SUITE— 510(k) K100094

Substantially Equivalent

Carestream Heatlh, Inc.

FDA 510(k) clearance K100094 for CARESTREAM IMAGE SUITE, Substantially Equivalent on 2010-03-11. Applicant: Carestream Heatlh, Inc.. Device class: 2.

Clearance details

Applicant
Carestream Heatlh, Inc.
Product code
Code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rochester, NY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code LLZ

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

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 K100094

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 K100094.

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