FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CDR PANX, MODEL 4792
K Number: K031291
·
Decision May 5, 2003
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
13
Review Days
12
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Basic Information
- Device Name
- CDR PANX, MODEL 4792
- K Number
- K031291
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schick Technologies, Inc.
- Date Received
- April 23, 2003
- Decision Date
- May 5, 2003
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- Y
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 |
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Other Clearances by Schick Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110768 | COMPUTED DENTAL RADIOGRAPHY | Apr 20, 2011 | Substantially Equivalent |
| K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Nov 30, 2009 | Substantially Equivalent |
| K072134 | SCHICK COMPUTED ORAL RADIOLOGY SYSTEM | Nov 2, 2007 | Substantially Equivalent |
| K053558 | CEPH, MODEL 4900 | Feb 17, 2006 | Substantially Equivalent |
| K041385 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Jun 7, 2004 | Substantially Equivalent |
| K022953 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Oct 2, 2002 | Substantially Equivalent |
| K001429 | MODIFICATION TO ACCUDEXA BONE DENSITOMETER | May 26, 2000 | Substantially Equivalent |
| K982661 | CDR - PAN MODEL 4700 | Dec 11, 1998 | Substantially Equivalent |
| K981124 | ACCUDEXA BONE DENSITOMETER | Jun 4, 1998 | Substantially Equivalent |
| K971735 | ACCUDEXA BONE DENSITOMETER | Dec 2, 1997 | Substantially Equivalent |