Cleared Traditional

Digiscan FDX (K200218) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200218 · Allengers Medical Systems Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
167d
Days
Class 2
Risk

K200218 is an FDA 510(k) clearance for the Digiscan FDX. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Allengers Medical Systems Limited (Derabassi, Distt Mohali, IN). The FDA issued a Cleared decision on July 13, 2020 after a review of 167 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Allengers Medical Systems Limited devices

Submission Details

510(k) Number K200218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2020
Decision Date July 13, 2020
Days to Decision 167 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 107d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 - OWB Interventional Fluoroscopic X-ray System

All 185
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K200218.
Cios Flow
K203504 · Siemens Medical Solutions USA, Inc. · Dec 2020
Alphenix, INFX-8000V/B, /S, V9.1
K203551 · Canon Medical Systems Corporation · Dec 2020
Ziehm Vision RFD 3D
K202360 · Ziehm Imaging GmbH · Sep 2020
ARTIS pheno (VE2)
K201156 · Siemens Medical Solution USA, Inc. · Jun 2020
ControlRad Trace Model 9
K200663 · Controlrad, Inc. · Jun 2020
CFP-3131, CFP-2222
K201172 · Mx Imaging, Inc. · May 2020