FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
TROPHYPAN
K Number: K023346
·
Decision Jan 3, 2003
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
16
Review Days
88
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Basic Information
- Device Name
- TROPHYPAN
- K Number
- K023346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trophy Radiologie
- Date Received
- October 7, 2002
- Decision Date
- January 3, 2003
- 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 |
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Other Clearances by Trophy Radiologie
| K Number | Device Name | ||
|---|---|---|---|
| K033690 | TROPHYPAN AND TROPHYPAN C | Feb 20, 2004 | Substantially Equivalent |
| K033419 | STV PRO 2 | Feb 2, 2004 | Substantially Equivalent |
| K012514 | DIGIPAN / DPI | Dec 21, 2001 | Substantially Equivalent |
| K991455 | ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, | Jun 25, 1999 | Substantially Equivalent |
| K991912 | MODIFICATION TO DIGIPAN | Jun 22, 1999 | Substantially Equivalent |
| K961826 | DIGIPAN | Sep 23, 1996 | Substantially Equivalent |
| K962337 | ELITYS OR ELITYS-E | Jul 25, 1996 | Substantially Equivalent |
| K953936 | ATLANTIS | Dec 28, 1995 | Substantially Equivalent |
| K951074 | STOMAVISION (STV) | Sep 19, 1995 | Substantially Equivalent |
| K950533 | TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY | Jun 30, 1995 | Substantially Equivalent |