DeviceClearance

DigitalDiagnost— 510(k) K210692

Substantially Equivalent

Philips Medical Systems Dmc GmbH

FDA 510(k) clearance K210692 for DigitalDiagnost, Substantially Equivalent on 2021-04-02. Applicant: Philips Medical Systems Dmc GmbH. Device class: 2.

Clearance details

Applicant
Philips Medical Systems Dmc GmbH
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
Hamburg, DE
Download summary PDFView on FDA.gov ↗

Recent devices under product code KPR

view all

More clearances from Philips Medical Systems Dmc GmbH

view all

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 K210692

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 K210692.

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