510(k) K955643
- Device
- Alara Imaging System
- Applicant
- DENOPTIX, INC.
- 510(k) number
- K955643
- Product code
- EGY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-01
- Date received
- 1995-12-12
- Regulation
- 892.1900
- Classification name
- Processor, Radiographic-Film, Automatic, Dental
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH RIMSA
- Address
- 270 Santa Ana Ct. Sunnyvale CA US 94086 94086
FDA Registration Numbers#
- 3014150341
- 2183301
Source Documents#
Other 510(k) Records For Product Code EGY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K992896 | DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) | Dental X-Ray Support Systems, Inc. | 1999-09-03 |
| K955825 | SMITH S-100 TIME & TEMPERATURE CONTROL | Smith Companies Dental Products | 1996-04-05 |
| K945682 | PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL | Gendex Corp. | 1995-02-09 |
| K900156 | AP201 DENTAL X-RAY FILM PROCESSOR | Allied Photo Products Co., Inc. | 1990-05-14 |
| K874118 | MODEL 410 DENTAL X-RAY FILM PROCESSORS | Dent-X Co. | 1987-11-06 |
| K811211 | YOSHIDA AP 100 | Kaycor Intl., Ltd. | 1981-06-16 |
| K771433 | AUTO. DEVEL. UNIT FOO DENTAL X-RAY | Ada Products Co., Inc. | 1977-08-19 |
| K770783 | FILM PROCESSOR, AUTOMATIC | General Electric Co. | 1977-05-10 |