DIGITAL SPOT IMAGING (DSI)— 510(k) K893131

Substantially Equivalent

Philips Medical Systems, Inc.

FDA 510(k) clearance K893131 for DIGITAL SPOT IMAGING (DSI), Substantially Equivalent on 1989-06-06. Applicant: Philips Medical Systems, Inc..

Clearance details

Applicant: Philips Medical Systems, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1989-04-25
Decision date: 1989-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 5680 Da Best, NL

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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