CTxx85 CT Scanner— 510(k) K201231

Name: FDA 510(k) clearance K201231
Creator: U.S. Food and Drug Administration
Published: 2021-02-02

Substantially Equivalent

Analogic Corporation

FDA 510(k) clearance K201231 for CTxx85 CT Scanner, Substantially Equivalent on 2021-02-02. Applicant: Analogic Corporation. Device class: 2.

Clearance details

Applicant: Analogic Corporation
Product code: Code JAK
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2020-05-07
Decision date: 2021-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Peabody, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Analogic Corporation

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K182147 — CTXX852018-09-07
K172058 — CT6485, CT128852018-02-13
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K140126 — SONIC WINDOW2014-03-04
K070829 — SYNEPIX 4600 DETECTOR2007-05-09

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.