FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ACCUDEXA BONE DENSITOMETER
K Number: K001429
·
Decision May 26, 2000
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
146
Applicant Total
13
Review Days
21
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Basic Information
- Device Name
- MODIFICATION TO ACCUDEXA BONE DENSITOMETER
- K Number
- K001429
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1170
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Schick Technologies, Inc.
- Date Received
- May 5, 2000
- Decision Date
- May 26, 2000
- Product Code
- KGI
- 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 |
|---|---|---|---|
| KGI | Densitometer, Bone | FDA class 2 | Radiology |
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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 |
| K031291 | CDR PANX, MODEL 4792 | May 5, 2003 | Substantially Equivalent |
| K022953 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | Oct 2, 2002 | 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 |