FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
K Number: K904599
·
Decision Apr 23, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
16
Applicant Total
1
Review Days
195
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Basic Information
- Device Name
- D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM
- K Number
- K904599
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1310
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Digital Design, Inc.
- Date Received
- October 10, 1990
- Decision Date
- April 23, 1991
- Product Code
- JWM
- 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 |
|---|---|---|---|
| JWM | System, Tomographic, Nuclear | FDA class 2 | Radiology |
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