FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
APEX 609R ANGER CAMERA
K Number: K884675
·
Decision Apr 17, 1989
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
129
Applicant Total
94
Review Days
160
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Basic Information
- Device Name
- APEX 609R ANGER CAMERA
- K Number
- K884675
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.1100
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Elscint, Inc.
- Date Received
- November 8, 1988
- Decision Date
- April 17, 1989
- Product Code
- IYX
- 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 |
|---|---|---|---|
| IYX | Camera, Scintillation (Gamma) | FDA class 1 | Radiology |
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| K972592 | 2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101) | Sep 15, 1997 | Substantially Equivalent |
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