VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.

K974077 · J. Morita USA, Inc. · EHD · Jan 20, 1998 · Dental

Device Facts

• Record ID: K974077
• Device Name: VERSAVIEW PANORAMIC-CEPHALOMETRIC DENTAL X-RAY SYS.
• Applicant: J. Morita USA, Inc.
• Product Code: EHD · Dental
• Decision Date: Jan 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

J.Morita USA, Inc.'s Versaview Panoramic-Cephalometric Dental X-Ray System ("Panoramic/Cephalometric System") is intended to take panoramic and cephalometric dental x-rays including anteriorposterior, posterior-anterior, and submentovortex views.

Device Story

System captures panoramic and cephalometric dental x-rays; includes x-ray control unit, upright assembly, x-ray head, collimator, and cephalometer. Dentist positions patient using forehead/zygoma stabilizers, bite block, and chin rest (panoramic) or forehead/rearhead stabilizers and ear rods (cephalometric). Dentist adjusts exposure voltage/amperage for panoramic or voltage/time for cephalometric modes; cephalometric amperage fixed at 10mA. Device produces film-based x-ray images for diagnostic use by dentists. Used in clinical dental settings.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Extraoral dental x-ray system. Components: x-ray control unit, upright assembly, x-ray head, collimator, cephalometer. Patient positioning assembly includes forehead/zygoma stabilizers, bite block, chin rest, rearhead stabilizer, and ear rods. Operates via manual exposure settings for voltage, amperage, and time. No software-based automation or digital processing described.

Indications for Use

Indicated for dental patients requiring panoramic and cephalometric x-ray imaging, including anterior-posterior, posterior-anterior, and submentovortex views.

Regulatory Classification

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.

Predicate Devices

• Kaycor International's Panoura ULTRA Pan/Ceph X-Ray Unit
• Kaycor International's Panoura-10C Pan/Ceph X-Ray Unit
• J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System

Submission Summary (Full Text)

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< 4.742.7

# J.Morita USA, Inc. Versaview Panoramic/Cephalometric Dental X-Ray System 510 (k) Summary

Submitter's Name, Address, and Telephone Number

J.Morita USA, Inc. JAN 20 1998 14712 Bentley Circle Tustin, CA 92680 Telephone: Facsimile:

Contact Person

Terry G. Mahn Fish & Richardson PC Suite 500 601 Thirteenth St., NW Washington, DC 20005 Telephone : [phone] [phone] Facsimile:

as Regulatory Counsel to J.Morita USA, Inc.

Date Prepared

October 21, 1997

Name of Device

Versaview Panoramic-Cephalometric Dental X-Ray System

Classification Name

Extraoral Dental X-Ray Device with Cephalometer

Common Name

Panoramic-Cephalometric Dental X-Ray System

#### Predicate Devices

Kaycor International's Panoura ULTRA Pan/Ceph X-Ray Unit Kaycor International's Panoura-10C Pan/Ceph X-Ray Unit J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System

### Intended Use

J.Morita USA, Inc.'s Versaview Panoramic-Cephalometric Dental X-Ray System ("Panoramic/Cephalometric System") is intended to take panoramic and cephalometric dental x-rays including anteriorposterior, posterior-anterior, and submentovortex views.

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## Substantial Equivalence

The Panoramic/Cephalometric System is a modification of J.Morita USA, Inc.'s Versaview Panoramic Dental X-Ray System. The modified device consists of a x-ray control unit, x-ray upright assembly, x-ray head, collimator, and cephalometer. The upright assembly and cephalometer have a patient positioning assembly which is used to position and hold the patient's head during a dental x-ray. The patient positioning assembly on the upright assembly consists of a forehead stabilizer, zygoma stabilizer, bite block, bite block cover, and chin rest. The patient positioning assembly on the cephalometer consists of forehead stabilizer, rearhead stabilizer, and ear rod.

To take a x-ray, the dentist positions the patient in one of the patient positioning assemblies and loads the film cassette on the cassette holder. If taking panoramic x-rays, the dentist adjusts the exposure voltage and amperage. If taking a cephalometric xray, the dentist adjusts the exposure voltage and time. The exposure amperage in cephalometric x-ray mode is automatically set at 10 milliamps. The dentist presses the emission button on the control unit's handswitch to take the x-ray. After the exposure is complete, the patient can move away from the x-ray.

The Panoramic/Cephalometric System is substantially equivalent to the predicate devices because they have the same intended use, principles of operation and technological characteristics. For instance, the devices have similar x-ray outputs, focal spot sizes, total filtration, and maximum tube voltage and current. In addition, the Panoramic/Cephalometric System and the Panoramic System have the same patient contacting materials.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 20 1998

J. Morita USA. Inc. c/o Fish & Richardson 601 13th Street, N.W. Suite 500 North Washington, DC 20005 Attn: Terry G. Mahn

Re: K974077

Versaview Panoramic-Cephalometric Dental X-Ray System Dated: October 28, 1997 Received: October 29, 1997 Regulatory class: II 21 CFR 872.1800/Procode: 90 EHD

Dear Mr. Mahn:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. -

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h. William Yu.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Versaview Panoramic-Cephalometric Dental X-Ray Device Name: System

## Indications For Use:

To take panoramic and cephalometric dental x-rays including anterior-posterior, posterior-anterior and submentovortex views.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
|-------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K974077 |

| Prescription Use | <img alt="prescription use" src="prescription_use.png"/> | OR | Over-The-Counter Use |
|-------------------------|----------------------------------------------------------|----|----------------------|
| (Per 21 C.F.R. 801.109) | | | |

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