FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMP-X,X-RAY GENERATOR
K Number: K925684
·
Decision Feb 2, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
162
Applicant Total
13
Review Days
82
Basic Information
- Device Name
- OLYMP-X,X-RAY GENERATOR
- K Number
- K925684
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AFP IMAGING CORP.
- Date Received
- November 12, 1992
- Decision Date
- February 2, 1993
- Product Code
- IZO
- 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | FDA class 1 | Radiology |
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| K974619 | SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM | Feb 25, 1998 | Substantially Equivalent |
| K950288 | AUTOLASER MULTI FORMAT CAMERA | Apr 4, 1995 | Substantially Equivalent |
| K925885 | AFP 17 X 4 AUTOMATIC FILM PROCESSOR | Jun 9, 1993 | Substantially Equivalent |
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