FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENCOMPASS
K Number: K141130
·
Decision Jul 30, 2014
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- ENCOMPASS
- K Number
- K141130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Panoramic Corp.
- Date Received
- May 1, 2014
- Decision Date
- July 30, 2014
- 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 Panoramic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Feb 4, 2016 | Substantially Equivalent |
| K110371 | ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY | Mar 17, 2011 | Substantially Equivalent |
| K043557 | MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS | Jan 13, 2005 | Substantially Equivalent |
| K943532 | PANORAMIC CORPORATION HDLX | Dec 7, 1994 | Substantially Equivalent |
| K882436 | LASER - 1000 | Aug 4, 1988 | Substantially Equivalent |
| K870236 | PANORAMIC X-RAY MODEL PC-1000 | Feb 13, 1987 | Substantially Equivalent |