The following data is part of a premarket notification filed by Progeny, Inc. with the FDA for Jb-70 Intraoral X-ray System, Models 30-a0001/a0002.
| Device ID | K020070 |
| 510k Number | K020070 |
| Device Name: | JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Contact | Alan Krema |
| Correspondent | Alan Krema PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-09 |
| Decision Date | 2002-02-01 |
| Summary: | summary |