FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
K Number: K123419
·
Decision Dec 27, 2012
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
13
Review Days
51
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
- EVA SELECT DIGITAL DENTAL IMAGING SYSTEM
- K Number
- K123419
- 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
- November 6, 2012
- Decision Date
- December 27, 2012
- Product Code
- MUH
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUH), ordered by most recent decision date.
SOTA Cloud Smart Sensor (1.5)
FDA 510(k)
FDA Class 2
·Dental
EzSensor HD, EzSensor UHD
FDA 510(k)
FDA Class 2
·Dental
Cocoon Solo (DX-7020s)
FDA 510(k)
FDA Class 2
·Dental
Digital X-Ray DentiMax Pro Imaging System
FDA 510(k)
FDA Class 2
·Dental
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
FDA 510(k)
FDA Class 2
·Dental
X Sensor (Model: IOS-A15IF, HDI-15DGF)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Afp Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K072357 | NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM | Sep 18, 2007 | Substantially Equivalent |
| K041120 | EV APAN DIGITAL, MODEL K1VSM2000 | Aug 30, 2004 | Substantially Equivalent |
| 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 |
| K013176 | MODIFICATION TO: SENS-A-RAY SYSTEM WITH PROIMAGE SOFTWARE | Oct 16, 2001 | 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 |