FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the surface of the dental arch and lateral images of the skull and lateral images of dentition, TM-joints using linear tomographic method.

Device Description

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AI/ML Overview

I apologize, but the provided text from the FDA 510(k) letters (K973642) for the Orthopantomograph® OP100 and Orthoceph® OC100 does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The letters primarily cover the following:

Approval of the 510(k) submission: Stating that the devices are substantially equivalent to pre-amendment devices.
Regulatory classification: Class II, 21 CFR 872.1800/Procode: 90 EHD.
General controls provisions: Annual registration, device listing, GMP, labeling, and prohibitions against misbranding and adulteration.
Contact information for further questions.
Indications for Use: Orthopantomograph® OP100 and Orthoceph® OC100 are intended to be used for producing diagnostic images of the dental arch, TM-joints, and lateral images using a linear tomographic method.

To answer your specific questions about acceptance criteria and performance studies, I would need a different type of document, such as:

A Clinical Study Report
A Performance Test Report
The Pre-market Notification (510(k)) Summary (which often contains more detail on performance data if it was required for substantial equivalence)
The Device's own technical specifications or validation documents

Without such information, I cannot provide details on the study design, acceptance criteria, or performance results.

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K Number

K955411

Device Name

DELTA 16

Manufacturer

INSTRUMENTARIUM IMAGING, INC.

Date Cleared

1996-03-21

(115 days)