OLDELFT THORASCAN MODEL NUMBER 180T— 510(k) K012165

Substantially Equivalent

Nucletron Corp.

FDA 510(k) clearance K012165 for OLDELFT THORASCAN MODEL NUMBER 180T, Substantially Equivalent on 2001-09-19. Applicant: Nucletron Corp..

Clearance details

Applicant: Nucletron Corp.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2001-07-11
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.