Cleared Traditional

K003936 - PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING

K003936 is an FDA 510(k) clearance for PANORAMIC SCAN, manufactured by Tomtec Imaging Systems GmbH. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K003936 · Tomtec Imaging Systems GmbH · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
56d
Days
Class 2
Risk

K003936 is an FDA 510(k) clearance for the PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Tomtec Imaging Systems GmbH (Unterschleissheim, DE). The FDA issued a Cleared decision on February 14, 2001 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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.

FDA 510(k) Submission Details - K003936

510(k) Number K003936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2000
Decision Date February 14, 2001
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 897
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K003936.
VHF ULTRASONIC ARC-SCAN SYSTEM
K003890 · Ultralink, LLC · May 2001
240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
K003725 · Pie Medical · Mar 2001
MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
K003672 · Medge Platforms, Inc. · Feb 2001
ULTRASOUND SCANNER TYPE 2101
K003041 · B & K Medical A/S · Feb 2001
260 CORVUS
K003292 · Pie Medical · Jan 2001
UBM PLUS, MODEL P45
K003141 · Paradigm Medical Industries, Inc. · Dec 2000
K003936 · PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING
Download PDF FDA Summary Tomtec Imaging System…