EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR— 510(k) K001550

Substantially Equivalent

Imatron, Inc.

FDA 510(k) clearance K001550 for EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR, Substantially Equivalent on 2000-12-11. Applicant: Imatron, Inc..

Clearance details

Applicant: Imatron, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2000-05-18
Decision date: 2000-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Fransisco, CA, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.