SUPERDIMENSION/BRONCHUS 4.1— 510(k) K052260

Clearance details

Applicant

Superdimension, Ltd.

Product code

Code JAK

Device class

Class 2

Regulation

21 CFR 892.1750

Advisory panel

Radiology

Date received

2005-08-19

Decision date

2005-09-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Hasbrouck Heights, NJ, US

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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 →

• Z-2001-2012 — superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.Class II·Terminated·superDimension, Inc·20120618

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052260.