FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PANORAMIC X-RAY MODEL PC-1000
K Number: K870236
·
Decision Feb 13, 1987
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
7
Review Days
23
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
- PANORAMIC X-RAY MODEL PC-1000
- K Number
- K870236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Panoramic Corp.
- Date Received
- January 21, 1987
- Decision Date
- February 13, 1987
- Product Code
- EHD
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Panoramic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Feb 4, 2016 | Substantially Equivalent |
| K141130 | ENCOMPASS | Jul 30, 2014 | 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 |