EGY
9 FDA 510(k) clearances · Product code
43 daysmedian time to decision
122 days90th percentile
9clearances measured
FDA profile
- Official device name
- Processor, Radiographic-Film, Automatic, Dental
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1900
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 2003: 1 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| ALARA IMAGING SYSTEM (K955643) | Denoptix, Inc. | 1996-03-01 |
| 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 |
Track EGY automatically
Every clearance here is in the API, with alerts when new ones post.