INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H— 510(k) K883649

Substantially Equivalent

Instrumentarium Corp.

FDA 510(k) clearance K883649 for INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H, Substantially Equivalent on 1988-10-19. Applicant: Instrumentarium Corp..

Clearance details

Applicant: Instrumentarium Corp.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1988-08-29
Decision date: 1988-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.