ALARA IMAGING SYSTEM
FDA 510(k) clearance K955643 · decided 1996-03-01
Clearance details
- K-number
- K955643
- Device name
- ALARA IMAGING SYSTEM
- Applicant
- Denoptix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-12
- Decision date
- 1996-03-01
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- EGY
- Device class
- 2
- Regulation number
- 892.1900
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830) (K992896) | Dental X-Ray Support Systems, Inc. | 1999-09-03 |
| SMITH S-100 TIME & TEMPERATURE CONTROL (K955825) | Smith Companies Dental Products | 1996-04-05 |
| PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL (K945682) | Gendex Corp. | 1995-02-09 |
| AP201 DENTAL X-RAY FILM PROCESSOR (K900156) | Allied Photo Products Co., Inc. | 1990-05-14 |
| MODEL 410 DENTAL X-RAY FILM PROCESSORS (K874118) | Dent-X Co. | 1987-11-06 |
| YOSHIDA AP 100 (K811211) | Kaycor Intl., Ltd. | 1981-06-16 |
| AUTO. DEVEL. UNIT FOO DENTAL X-RAY (K771433) | Ada Products Co., Inc. | 1977-08-19 |
| FILM PROCESSOR, AUTOMATIC (K770783) | General Electric Co. | 1977-05-10 |
Recalls involving this device
No recalls on record reference this clearance.