Cleared Traditional

K033485 - ENDOSCOUT

K033485 is an FDA 510(k) clearance for ENDOSCOUT, manufactured by Robin Medical, Inc.. The device is a Class 2 Radiology device with product code LNH cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K033485 · Robin Medical, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
168d
Days
Class 2
Risk

K033485 is an FDA 510(k) clearance for the ENDOSCOUT. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Robin Medical, Inc. (M.P. Misgav, IL). The FDA issued a Cleared decision on April 20, 2004 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Robin Medical, Inc. devices

FDA 510(k) Submission Details - K033485

510(k) Number K033485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date April 20, 2004
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNH Device Classification - Class 2, Special Controls

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
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 - LNH System, Nuclear Magnetic Resonance Imaging

All 883
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K033485.
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K041577 · Adac Laboratories · Jun 2004
GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM
K041476 · Ge Medical Systems, LLC · Jun 2004
ARTOSCAN C
K040877 · Esaote, S.P.A. · May 2004
GE SIGNA 3.0T WITH EXCITE MR SYSTEM
K040444 · General Electric Co. · Apr 2004
GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS
K033867 · General Electric Co. · Dec 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K033504 · General Electric Co. · Nov 2003