FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERIES OF DIAGNOSTIC PHANTOMS
K Number: K834465
·
Decision Feb 21, 1984
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
3
Applicant Total
1
Review Days
63
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Basic Information
- Device Name
- SERIES OF DIAGNOSTIC PHANTOMS
- K Number
- K834465
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1950
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cirs, Inc.
- Date Received
- December 20, 1983
- Decision Date
- February 21, 1984
- Product Code
- IXG
- 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 |
|---|---|---|---|
| IXG | Phantom, Anthropomorphic, Radiographic | FDA class 1 | Radiology |
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