EGY · Processor, Radiographic-Film, Automatic, Dental
Radiology · 21 CFR 892.1900 · Class 2
Overview
| Product Code | EGY |
|---|---|
| Device Name | Processor, Radiographic-Film, Automatic, Dental |
| Regulation | 21 CFR 892.1900 |
| Device Class | Class 2 |
| Review Panel | Radiology |
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 | DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) | Dental X-Ray Support Systems, Inc. | Sep 3, 1999 | SESE |
| K955825 | SMITH S-100 TIME & TEMPERATURE CONTROL | Smith Companies Dental Products | Apr 5, 1996 | SESE |
| K955643 | ALARA IMAGING SYSTEM | Denoptix, Inc. | Mar 1, 1996 | SESE |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | Gendex Corp. | Feb 9, 1995 | SESE |
| K900156 | AP201 DENTAL X-RAY FILM PROCESSOR | Allied Photo Products Co., Inc. | May 14, 1990 | SESE |
| K874118 | MODEL 410 DENTAL X-RAY FILM PROCESSORS | Dent-X Co. | Nov 6, 1987 | SESE |
| K811211 | YOSHIDA AP 100 | Kaycor Intl., Ltd. | Jun 16, 1981 | SESE |
| K771433 | AUTO. DEVEL. UNIT FOO DENTAL X-RAY | Ada Products Co., Inc. | Aug 19, 1977 | SESE |
| K770783 | 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
