FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CDR - PAN MODEL 4700
K Number: K982661
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
13
Review Days
134
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
- CDR - PAN MODEL 4700
- K Number
- K982661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schick Technologies, Inc.
- Date Received
- July 30, 1998
- Decision Date
- December 11, 1998
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQB), ordered by most recent decision date.
VIVIX-S 4386W (FXRD-4386WA)
FDA 510(k)
FDA Class 2
·Radiology
Universal 1417PI
FDA 510(k)
FDA Class 2
·Radiology
Lux HD 2530 detector (Lux HD 2530)
FDA 510(k)
FDA Class 2
·Radiology
Yushan X-Ray Flat Panel Detector
FDA 510(k)
FDA Class 2
·Radiology
SKR 3000
FDA 510(k)
FDA Class 2
·Radiology
Wireless/ Wired X-Ray Flat Panel Detectors
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K001429 | MODIFICATION TO ACCUDEXA BONE DENSITOMETER | May 26, 2000 | Substantially Equivalent |
| K981124 | ACCUDEXA BONE DENSITOMETER | Jun 4, 1998 | Substantially Equivalent |
| K971735 | ACCUDEXA BONE DENSITOMETER | Dec 2, 1997 | Substantially Equivalent |