Cleared Traditional

ORTHOPANTOMOGRAPH OP100D

K992385 · Instrumentarium Corp. · Radiology
Sep 1999
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K992385 is an FDA 510(k) clearance for the ORTHOPANTOMOGRAPH OP100D, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Instrumentarium Corp. (Milwaukee, US). The FDA issued a Cleared decision on September 28, 1999, 74 days after receiving the submission on July 16, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K992385 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1999
Decision Date September 28, 1999
Days to Decision 74 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

Similar Devices — MUH System, X-ray, Extraoral Source, Digital

All 205
SOTA Cloud Smart Sensor (1.5)
K251793 · Sota Cloud Corp. · Mar 2026
EzSensor HD, EzSensor UHD
K252570 · Qpix Solutions, Inc. · Nov 2025
Cocoon Solo (DX-7020s)
K250687 · Dexcowin Global, Inc. · Oct 2025
Digital X-Ray DentiMax Pro Imaging System
K251206 · Dentimax, Inc. · Sep 2025
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
K240040 · VATECH Co., Ltd. · Oct 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · Qpix Solutions, Inc. · Oct 2024