INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER— 510(k) K940671

Substantially Equivalent

Interspec, Inc.

FDA 510(k) clearance K940671 for INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER, Substantially Equivalent on 1994-11-22. Applicant: Interspec, Inc..

Clearance details

Applicant: Interspec, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1994-02-16
Decision date: 1994-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ambler, PA, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.