Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1900](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1900) → EGY — Processor, Radiographic-Film, Automatic, Dental

# EGY · Processor, Radiographic-Film, Automatic, Dental

_Radiology · 21 CFR 892.1900 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY

## Overview

- **Product Code:** EGY
- **Device Name:** Processor, Radiographic-Film, Automatic, Dental
- **Regulation:** [21 CFR 892.1900](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1900)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (9 of 9)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K992896](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K992896.md) | DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) | Dental X-Ray Support Systems, Inc. | Sep 3, 1999 | SESE |
| [K955825](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K955825.md) | SMITH S-100 TIME & TEMPERATURE CONTROL | Smith Companies Dental Products | Apr 5, 1996 | SESE |
| [K955643](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K955643.md) | ALARA IMAGING SYSTEM | Denoptix, Inc. | Mar 1, 1996 | SESE |
| [K945682](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K945682.md) | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | Gendex Corp. | Feb 9, 1995 | SESE |
| [K900156](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K900156.md) | AP201 DENTAL X-RAY FILM PROCESSOR | Allied Photo Products Co., Inc. | May 14, 1990 | SESE |
| [K874118](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K874118.md) | MODEL 410 DENTAL X-RAY FILM PROCESSORS | Dent-X Co. | Nov 6, 1987 | SESE |
| [K811211](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K811211.md) | YOSHIDA AP 100 | Kaycor Intl., Ltd. | Jun 16, 1981 | SESE |
| [K771433](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K771433.md) | AUTO. DEVEL. UNIT FOO DENTAL X-RAY | Ada Products Co., Inc. | Aug 19, 1977 | SESE |
| [K770783](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY/K770783.md) | FILM PROCESSOR, AUTOMATIC | General Electric Co. | May 10, 1977 | SESE |

## Top Applicants

- Smith Companies Dental Products — 1 clearance
- Kaycor Intl., Ltd. — 1 clearance
- General Electric Co. — 1 clearance
- Gendex Corp. — 1 clearance
- Dental X-Ray Support Systems, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EGY)

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