FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
K Number: K020070
·
Decision Feb 1, 2002
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
5
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002
- K Number
- K020070
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Progeny, Inc.
- Date Received
- January 9, 2002
- Decision Date
- February 1, 2002
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Progeny, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | May 1, 2009 | Substantially Equivalent |
| K070664 | PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). | Apr 26, 2007 | Substantially Equivalent |
| K043092 | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 | Dec 13, 2004 | Substantially Equivalent |
| K041831 | PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR | Aug 9, 2004 | Substantially Equivalent |