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K Number
K973642
Device Name
ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100
Manufacturer
INSTRUMENTARIUM IMAGING, INC.
Date Cleared
1997-11-21

(58 days)

Product Code
EHD
Regulation Number
872.1800
Type
Traditional
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Not Found

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.

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.