FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
K Number: K974619
·
Decision Feb 25, 1998
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
60
Applicant Total
13
Review Days
76
Basic Information
- Device Name
- SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM
- K Number
- K974619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2030
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AFP IMAGING CORP.
- Date Received
- December 11, 1997
- Decision Date
- February 25, 1998
- Product Code
- LMA
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| LMA | Digitizer, Image, Radiological | FDA class 2 | Radiology |
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Other Clearances by AFP IMAGING CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K123419 | EVA SELECT DIGITAL DENTAL IMAGING SYSTEM | Dec 27, 2012 | Substantially Equivalent |
| 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 |
| 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 |