FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION
K Number: K833941
·
Decision Dec 29, 1983
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
733
Applicant Total
20
Review Days
44
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Basic Information
- Device Name
- ORION
- K Number
- K833941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Cgr Medical Corp.
- Date Received
- November 15, 1983
- Decision Date
- December 29, 1983
- Product Code
- IYE
- 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | FDA class 2 | Radiology |
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Other Clearances by Cgr Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K843926 | PRESTILIX 1690 | Dec 17, 1984 | Substantially Equivalent |
| K843235 | STENOSCOP | Nov 8, 1984 | Substantially Equivalent |
| K843985 | SUSPENSION 7 | Nov 5, 1984 | Substantially Equivalent |
| K841649 | MAXIMAX - 4 | Jun 5, 1984 | Substantially Equivalent |
| K833223 | SONEL 3000A | May 9, 1984 | Substantially Equivalent |
| K834306 | PHASIX-HIGH FREQUENCY GENERATOR | Dec 29, 1983 | Substantially Equivalent |
| K833846 | PROCESS 100 ST | Dec 16, 1983 | Substantially Equivalent |
| K837412 | SATURNE I LINEAR ACCELERATOR | Jun 28, 1983 | Substantially Equivalent |
| K837465 | ALCYON ROTATIONAL COBALT THERAPY | Jun 28, 1983 | Substantially Equivalent |
| K837336 | VERASUN RADIATION THERAPY SIMULATION SYSTEM | Apr 29, 1983 | Substantially Equivalent |