Cleared Traditional

K071473 - MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2

K071473 is an FDA 510(k) clearance for MODIFICATION TO SUPERDIMENSION/BRONCHUS..., manufactured by Superdimension, Ltd.. The device is a Class 2 Radiology device with product code EOQ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K071473 · Superdimension, Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Jul 2007
Decision
44d
Days
Class 2
Risk

K071473 is an FDA 510(k) clearance for the MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Superdimension, Ltd. (Lakewood, US). The FDA issued a Cleared decision on July 12, 2007 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Superdimension, Ltd. devices

FDA 510(k) Submission Details - K071473

510(k) Number K071473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date July 12, 2007
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 199
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K071473.
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