FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
K Number: K013176
·
Decision Oct 16, 2001
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
13
Review Days
22
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Basic Information
- Device Name
- MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE
- K Number
- K013176
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Afp Imaging Corp.
- Date Received
- September 24, 2001
- Decision Date
- October 16, 2001
- 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 |
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|---|---|---|---|
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| K030647 | EVA DIGITAL DENTAL X-RAY SYSTEM | Mar 20, 2003 | Substantially Equivalent |
| K014144 | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 | Feb 7, 2002 | Substantially Equivalent |
| K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | Feb 25, 1998 | Substantially Equivalent |
| K950288 | AUTOLASER MULTI FORMAT CAMERA | Apr 4, 1995 | Substantially Equivalent |
| K925885 | AFP 17 X 4 AUTOMATIC FILM PROCESSOR | Jun 9, 1993 | Substantially Equivalent |
| K930761 | IMAGE-X 70 INTRAORAL X-RAY SYSTEM | May 25, 1993 | Substantially Equivalent |
| K925684 | OLYMP-X,X-RAY GENERATOR | Feb 2, 1993 | Substantially Equivalent |