PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT

K965072 · Kaycor Intl., Ltd. · EHD · Jan 27, 1997 · Dental

Device Facts

• Record ID: K965072
• Device Name: PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT
• Applicant: Kaycor Intl., Ltd.
• Product Code: EHD · Dental
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken. These uses are typical of the predicate devices in the Panoura-10 series.

Device Story

Microprocessor-controlled panoramic/cephalometric X-ray system; produces dental radiographs for diagnostic use. Patient positioned by integrated unit devices; operator initiates exposure. X-ray source and film rotate to capture image. Used in dental, oral surgery, and orthodontic clinics. Output is a panoramic or cephalometric film used by clinicians for diagnostic assessment. Benefits include standardized diagnostic imaging for dental and orthodontic treatment planning.

Clinical Evidence

Bench testing only. Preproduction testing compared radiographs of the same patient produced on the subject device and the predicate device, concluding that the images were essentially identical.

Technological Characteristics

Microprocessor-controlled X-ray generator; self-rectified 50/60 Hz; 1.0 mm focal spot; 2.8 mm Al equivalent filtration; 90 kVp max voltage; 6 mA (panoramic) / 10 mA (cephalometric) max current. Digital control display. Form factor: panoramic or cephalometric configurations.

Indications for Use

Indicated for diagnostic radiographic imaging in dental, oral surgery, and orthodontic patients requiring panoramic or cephalometric dental radiographs.

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

• Yoshida/Kaycor Panoura-10 Panoramic X-ray Unit (K811210)
• Yoshida Kaycor Panoura-10C Panoramic/Cephalometric X-ray Unit (K811210)

Submission Summary (Full Text)

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JAN 24 1997
K965072

# EXHIBIT A

Kaycor International Ltd.
3611 Commercial Avenue
Northbrook, IL 60062 USA
847-564-4334
Fax: [phone]
Contact Name: Keith R. Kretchmer
December 18, 1996

## 510(k) Summary of Safety and Effectiveness

### 1. Identification of the Device

**Classification Name:** Extraoral source X-ray system, 76EHD, Reg. # 872.1800

**Common/Usual Name:** Panoramic dental X-ray system

**Proprietary-Trade Name:** Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric X-ray Unit.

### 2. Equivalent legally marketed devices

This product is similar in design and function to the Yoshida/Kaycor Panoura-10 Panoramic X-ray Unit, and Yoshida Kaycor Panoura-10C Panoramic/Cephalometric X-ray Unit. (K811210)

### 3. Indications for Use (intended use)

The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph will be marketed for diagnostic radiographic use in dental, oral surgery, and orthodontic practices, and in other medical facilities where these types of dental radiographs are routinely taken. These uses are typical of the predicate devices in the Panoura-10 series.

### 4. Description of the Device:

The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric X-ray Units are microprocessor controlled X-ray generator and film handling units designed mainly for dental applications. The patient stands facing the unit and is positioned by devices built into the unit. The exposure is begun under control of the operator, and the X-ray source and film rotate so as to produce a panoramic film for diagnostic use.

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5. Safety and Effectiveness, comparison to predicate device.

The Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph Panoramic/Cephalometric X-ray Units, are substantially equivalent to the Yoshida/Kaycor Panoura-10 Panoramic X-ray Unit, and Yoshida Kaycor Panoura-10C Panoramic/Cephalometric X-ray Units, and are substantially equivalent in safety and effectiveness. Preproduction testing showed that radiographs of the same patient produced on either device were essentially identical. The chart below compares the new and predicate devices.

6. Substantial Equivalence Chart

| Feature | Panoura ULTRA Pan and Panoura ULTRA Pan/Ceph (new device) | Panoura-10 Series (predicate device) |
| --- | --- | --- |
| X-ray output | | |
| Panoramic mode | 6 mA @ 70 - 90 kVp in 6 steps | 6 mA @ 70 - 90 kVp continuously variable |
| Cephalometric mode | 10 mA @ 70 - 90 kVp in 6 steps | 10 mA @ 70 - 90 kVp continuously variable |
| Timer | | |
| Panoramic mode | 12, 14, or 16 seconds | 12 seconds |
| Cephalometric mode | 0.05-4.0 sec., 28 steps | 0.4-5.0 sec., 12 steps |
| X-ray generator | Self-rectified, 50/60 Hz | Self-rectified, 50/60 Hz |
| X-ray tube | Superior SXR-15 or equal | Toshiba D-103S or equal |
| Focal spot size | 1.0 mm | 1.0 mm |
| Total filtration | 2.8 mm Al equiv. | 2.8 mm Al. equiv. |
| Footprint, panoramic | 34.06" (86.5 cm) W, 40.0" (101.4 cm) D | 34.5" (87.63 cm) W, 41.0" (104.14 cm) D |
| Footprint, cephalometric | 72.0" (182.88 cm) W, 40.0" (101.4 cm) D | 72.0" (182.88) W, 41.0 (104.14 cm) D |
| Control display | Digital | Analog |
| Maximum tube voltage | 90 kVp | 90 kVp |
| Maximum tube current | | |
| Panoramic | 6 mA | 6 mA |
| Cephalometric | 10 mA | 10 mA |

7. Conclusion

Since there are no new indications for use nor are there any new potential hazards and preproduction testing showed that radiographs of the same patient produced on either device were essentially identical, Kaycor is of the opinion that the devices are substantially equivalent