ALARA IMAGING SYSTEM

K955643 · Denoptix, Inc. · EGY · Mar 1, 1996 · Radiology

Device Facts

• Record ID: K955643
• Device Name: ALARA IMAGING SYSTEM
• Applicant: Denoptix, Inc.
• Product Code: EGY · Radiology
• Decision Date: Mar 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

Intended Use

The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.

Device Story

Digital dental radiography system; utilizes reusable phosphor storage screens (Denta-screens) to capture X-ray exposures; ALARA Scanner (laser scanner/optical reader) digitizes latent images from screens; workstation computer processes, displays, and stores images; operator interface via keyboard/mouse; output viewed on CRT monitor; hard copies produced via laser printer; phosphor screens erased via external light box; used in dental clinical settings by dental professionals; facilitates diagnostic review and electronic archiving of dental radiographs.

Clinical Evidence

Bench testing only. Physical testing demonstrated performance in accordance with product specifications and equivalence to the Digora device. No clinical data provided.

Technological Characteristics

System components: reusable phosphor storage screens, laser scanner/optical reader, workstation computer, CRT monitor, laser printer, and light box eraser. Connectivity: workstation-based image processing and storage. Software: proprietary workstation software for image retrieval, viewing, and processing.

Indications for Use

Indicated for dental patients requiring intraoral and extraoral radiographic diagnostic imaging.

Regulatory Classification

Identification

An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Digora device (K934949)
• DIGISCAN 2 (K924459)
• DIGISCAN (K884621)
• Computed Radiography DMS CRT Image Consoles (K924012)
• Computed Radiography DMS CRT Image Consoles (K923990)

Submission Summary (Full Text)

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K955643

# Attachment 14
## 510(k) Summary Statement for the ALARA Imaging System

### I. General Information

**Submitter:** DenOptix Inc.
270 Santa Ana Court
Sunnyvale, CA 94086

**Contact Person:** Joseph Rimsa

**Summary Preparation Date:** December 11, 1995

### II. Names

**Device Names:** ALARA Imaging System

**Primary Classification Name:** Electrostatic X-ray Imaging System (90 IXK)

### III. Predicate Devices

- Digora device (K934949), marketed by Orion/Soredex;
- DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens Medical Systems, Inc.;
- Computed Radiography DMS CRT Image Consoles (K924012 and K923990), marketed by Fuji Medical Systems USA, Inc.

### IV. Product Description

The ALARA Imaging System is digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral dental images.

ALARA Imaging System is comprised of the following main components:

- Reusable phosphor storage screens (Denta-screens) with commercially available disposable storage screen covers;
- The ALARA Scanner, an image reader/digitizer (laser scanner and optical reader);
- The ALARA Scanner/Workstation Communications Interface;
- The ALARA Imaging System Workstation, with a CRT monitor, a workstation computer (the image processor), a keyboard and mouse (operator interface), proprietary workstation software, a floppy drive, and an optical hard drive (or digital analog tape) that is either resident in or attached to the workstation computer (image storage devices);
- A compatible commercially available laser printer (hard copy device);
- A commercially available light box used to “erase” the phosphor storage screen “eraser”; and
- Any compatible commercially available mass storage device(s) as backup electronic archive device(s).

510(k) for DenOptix ALARA Imaging System
Attachment 14 - Page 1

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# V. Indications for Use

The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.

# VI. Rationale for Substantial Equivalence

The ALARA Imaging System shares the same indications for use, similar materials and design features, functional features, and therefore are substantially equivalent to the Digora device (K934949), marketed by Orion/Soredex, the DIGISCAN 2 and DIGISCAN devices (K924459 and K884621), marketed by Siemens Medical Systems, Inc., and the Computed Radiography DMS CRT Image Consoles (K924012 and K923990), marketed by Fuji Medical Systems USA, Inc.

# VI. Safety and Effectiveness Information

Physical testing was performed to demonstrate that the performance of the DenOptix phosphor storage screens with the ALARA Imaging System is in accordance with the product specifications and equivalent to the labeled performance of the Digora device. In addition, the plastic envelope material that is used to cover the storage phosphor screens is a commercially available biocompatible product that is used to cover dental X-Ray film to provide protection from cross-contamination.

# VI. Conclusion

The ALARA Imaging System was found to be substantially equivalent to the currently marketed predicate devices, the Digora, the DIGISCAN 2 and DIGISCAN, and the Computed Radiography DMS CRT Image Consoles. The ALARA Imaging Systems share the same indications for use, similar design features, and similar functional features as the currently marketed Digora, DIGISCAN 2 and DIGISCAN, and Computed Radiography DMS CRT Image Consoles. The physical test results demonstrated that the Alara imaging system have acceptable performance characteristics.

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510(k) for DenOptix ALARA Imaging System

Attachment 14 - Page 2