FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
K Number: K955251
·
Decision Apr 12, 1996
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
81
Applicant Total
2
Review Days
149
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Basic Information
- Device Name
- OEC 902, 901 NASA II, OEC 902, 901 NASA I CCD C-ARM
- K Number
- K955251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imaging Services, Inc.
- Date Received
- November 15, 1995
- Decision Date
- April 12, 1996
- Product Code
- OXO
- 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 |
|---|---|---|---|
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | FDA class 2 | Radiology |
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Other Clearances by Imaging Services, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010772 | ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM | Aug 23, 2001 | Substantially Equivalent |