Cleared Traditional

K991455 - ORTHOSLICE OS1000 SERIES

Also marketed or referenced as:
PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C,

K991455 is an FDA 510(k) clearance for ORTHOSLICE OS1000 SERIES, manufactured by Trophy Radiologie. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K991455 · Trophy Radiologie · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
60d
Days
Class 2
Risk

K991455 is an FDA 510(k) clearance for the ORTHOSLICE OS1000 SERIES. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Trophy Radiologie (Marne La Vallee Cedex 2, FR). The FDA issued a Cleared decision on June 25, 1999 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Trophy Radiologie devices

FDA 510(k) Submission Details - K991455

510(k) Number K991455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date June 25, 1999
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 94
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K991455.
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
K000061 · Minxray, Inc. · Apr 2000
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
K994285 · Dentsply Intl. · Mar 2000
GENDEX 765DC, MODEL 110-0154
K992610 · Dentsply Intl. · Sep 1999
MODIFICATION TO DIGIPAN
K991912 · Trophy Radiologie · Jun 1999
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
K980581 · Planmeca Oy · Apr 1998
DENOPTIX BARRIER ENVELOPE (SIZE 0-4)
K980543 · Dentsply Intl. · Apr 1998