FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM
K Number: K862415
·
Decision Jul 1, 1986
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
33
Applicant Total
14
Review Days
6
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Basic Information
- Device Name
- TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM
- K Number
- K862415
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- June 25, 1986
- Decision Date
- July 1, 1986
- Product Code
- IWZ
- 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 |
|---|---|---|---|
| IWZ | Film, Radiographic | FDA class 1 | Radiology |
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|---|---|---|---|
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