FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K Number: K973463
·
Decision Dec 2, 1997
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
54
Applicant Total
4
Review Days
81
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Basic Information
- Device Name
- OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
- K Number
- K973463
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2010
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- O Tech, Inc.
- Date Received
- September 12, 1997
- Decision Date
- December 2, 1997
- 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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