FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-ARM CEILING CRANE FT-2
K Number: K840225
·
Decision Mar 22, 1984
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
299
Applicant Total
14
Review Days
63
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Basic Information
- Device Name
- C-ARM CEILING CRANE FT-2
- K Number
- K840225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medicor USA , Ltd.
- Date Received
- January 19, 1984
- Decision Date
- March 22, 1984
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
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Other Clearances by Medicor USA , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K861994 | MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM | Jul 18, 1986 | Substantially Equivalent |
| K861995 | MODEL RS-3 RADIOGRAPHIC STAND | Jun 19, 1986 | Substantially Equivalent |
| K860025 | MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR | May 7, 1986 | Substantially Equivalent |
| K850761 | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | Sep 19, 1985 | Substantially Equivalent |
| K851358 | MODEL BION 2/TYPE 90 ROOM IONIZER | Jul 1, 1985 | Substantially Equivalent |
| K851094 | MODEL BION 1/TYPE 1084T CAR IONIZER | Jun 19, 1985 | Substantially Equivalent |
| K843335 | FLOOR MOUNTED X-RAY TUBESTAND | Nov 27, 1984 | Substantially Equivalent |
| K840227 | UROLIX-3 UROLOGICAL TABLE | Mar 23, 1984 | Substantially Equivalent |
| K840226 | MOTOR TILTED EXAM. TABLE UV-56 | Mar 16, 1984 | Substantially Equivalent |
| K823695 | CPM METABOLIC MONITOR | Jan 14, 1983 | Substantially Equivalent |