FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ND3100 VIDEO IMAGER
K Number: K843349
·
Decision Dec 17, 1984
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
7
Review Days
112
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Basic Information
- Device Name
- ND3100 VIDEO IMAGER
- K Number
- K843349
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Nuclear Data, Inc.
- Date Received
- August 27, 1984
- Decision Date
- December 17, 1984
- Product Code
- LMB
- 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 |
|---|---|---|---|
| LMB | Device, Digital Image Storage, Radiological | FDA class 1 | Radiology |
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Other Clearances by Nuclear Data, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891466 | ACCUSPEC THYROID UPTAKE SYSTEM | Jun 6, 1989 | Substantially Equivalent |
| K881383 | ND1100 BONE DENSITY SCANNER | May 22, 1989 | Substantially Equivalent |
| K844835 | ND2100 SPINE SCANNER | Apr 18, 1985 | Substantially Equivalent |
| K844766 | ND1100 BONE DENSITY SCANNER | Apr 16, 1985 | Substantially Equivalent |
| K841440 | ND62T THYROID UPTAKE SYSTEM | Jun 5, 1984 | Substantially Equivalent |
| K841352 | ND1200 RIA COUNTER | May 2, 1984 | Substantially Equivalent |