DeviceClearance

DRX-Compass— 510(k) K201373

Substantially Equivalent

Carestream Health, Inc.

FDA 510(k) clearance K201373 for DRX-Compass, Substantially Equivalent on 2020-06-26. Applicant: Carestream Health, Inc.. Device class: 2.

Clearance details

Applicant
Carestream Health, Inc.
Product code
Code KPR
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
China (Shanghai) Pilot Free Trade Zone, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KPR

product code KPR
Other
6
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 K201373

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 K201373.

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