K Number
K962120
Device Name
TOMOGRAPH ACCESSORIES
Manufacturer
Date Cleared
1996-07-25

(55 days)

Product Code
Regulation Number
872.1800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The tomograph accessories are indicated for use in conjunction with a tomographic x-ray system to produce radiological images.
Device Description
Steri-Oss has designed a series of products to be used as a complement to a tomography system. These products aid in the positioning of dental patients for radiological imaging. A tomograph has the ability to take a cross-sectional view of dentition. In order to optimize the results obtained from tomography, patient positioning indices may be used. The products submitted are manufactured of varying materials and are designed to assist in the use of a tomographic x-ray unit.
More Information

Not Found

Not Found

No
The description focuses on physical accessories for patient positioning and does not mention any software or algorithms that would suggest AI/ML.

No
The device aids in patient positioning for radiological imaging, which is a diagnostic procedure, not a therapeutic one.

No
The device aids in patient positioning for radiological imaging, which is a part of image acquisition, not the interpretation or diagnosis using those images.

No

The device description explicitly states the products are "manufactured of varying materials" and are designed to assist in patient positioning, indicating they are physical accessories, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential transfusions, or to monitor therapeutic measures.
  • Device Function: The description clearly states that these accessories are used in conjunction with a tomographic x-ray system to produce radiological images. They are positioning aids for dental patients during imaging.
  • No Specimen Examination: The device does not examine any specimens derived from the human body. It facilitates the imaging process itself.
  • Focus on Imaging, Not Diagnosis from Specimens: The output is a radiological image, which is then interpreted by a healthcare professional. The device itself does not perform any diagnostic tests on biological samples.

Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics. It is a medical device used in the process of obtaining diagnostic images, but it is not an IVD.

N/A

Intended Use / Indications for Use

The tomograph accessories are indicated for use in conjunction with a tomographic x-ray system to produce radiological images.

Product codes

Not Found

Device Description

Steri-Oss has designed a series of products to be used as a complement to a tomography system. These products aid in the positioning of dental patients for radiological imaging.
A tomograph has the ability to take a cross-sectional view of dentition. In order to optimize the results obtained from tomography, patient positioning indices may be used.
The products submitted are manufactured of varying materials and are designed to assist in the use of a tomographic x-ray unit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

dentition

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Image /page/0/Picture/0 description: The image shows the logo for STERI-OSS, a Bausch & Lomb company. The logo consists of a stylized graphic to the left of the text "STERI-OSS". Below the text is the phrase "A BAUSCH & LOMB Company" in a smaller font. The text is in a bold, sans-serif font.

K 962120

Original 510(k) Tomograph Accessories

Jul 25 1996

Section 7

510(k) Summary

Manufacturer Information:

Submitter's Name:Steri-Oss Inc.
Address:22895 Eastpark Drive
Yorba Linda, CA 92687
U.S.A.
Contact's Name:Paul Gasser
Regulatory Affairs Specialist
Phone:714-282-6515
Date Prepared:June 1996

Device Names:

Common Name: Tomograph accessories

Trade Name: None

Tomographic X-ray system Classification Name:

Predicate Device:

Substantial equivalence is claimed to Siemens Orthophos Plus.

Device Description:

How device functions: Steri-Oss has designed a series of products to be used as a complement to a tomography system. These products aid in the positioning of dental patients for radiological imaging.

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Steri-Oss Inc. - May 1996

Steri-Oss Inc. 22895 East Park Drive Yorks Linda, CA 92687 · (714) 282-6515 Fax: (714) 998-9236 · (800) 993-8100

1

Original 510(k) Tomograph Accessories

Device Description (cont.):

Scientific concepts: A tomograph has the ability to take a cross-sectional view of dentition. In order to optimize the results obtained from tomography, patient positioning indices may be used.

Characteristics: The products submitted are manufactured of varying materials and are designed to assist in the use of a tomographic x-ray unit.

Intended Use:

The tomograph accessories are indicated for use in conjunction with a tomographic x-ray system to produce radiological images.

Comparison to Predicate:

The Siemens Orthophos Plus product is designed to take radiological images. As a built-in feature of this unit, it contains built-in components to aid in the positioning of the dental patient while the image is being taken.

Steri-Oss' products are designed to aid in the positioning of the dental patient as well; however, the products are intended to be supplemental to existing radiographic units.

Performance Data:

Not applicable.

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