FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-RAY SCANNER, WHOLE BODY, AS&E
K Number: K761004
·
Decision Dec 16, 1976
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
41
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- X-RAY SCANNER, WHOLE BODY, AS&E
- K Number
- K761004
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1740
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- American Science and Engineering, Inc.
- Date Received
- November 8, 1976
- Decision Date
- December 16, 1976
- Product Code
- IZF
- 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 |
|---|---|---|---|
| IZF | System, X-Ray, Tomographic | FDA class 2 | Radiology |
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