FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X-RAY SYSTEM
K Number: K780963
·
Decision Jun 27, 1978
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
69
Applicant Total
14
Review Days
15
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Basic Information
- Device Name
- X-RAY SYSTEM
- K Number
- K780963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5840
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- General X-Ray, Inc.
- Date Received
- June 12, 1978
- Decision Date
- June 27, 1978
- Product Code
- KPQ
- 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 |
|---|---|---|---|
| KPQ | System, Simulation, Radiation Therapy | FDA class 2 | Radiology |
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Other Clearances by General X-Ray, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K800998 | ATLAS-S X-RAY SYSTEM W/KETROMAT GEN. | May 28, 1980 | Substantially Equivalent |
| K790451 | X-RAY UNITS, GX-101, UCIS-510 AND GX-111 | Mar 28, 1979 | Substantially Equivalent |
| K790512 | PORTABLE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790511 | MOBILE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790392 | 510 CARBINETTE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790443 | PORTABLE X-RAY UNIT | Mar 26, 1979 | Substantially Equivalent |
| K790393 | PORTABLE X-RAY UNIT, MATRIX S GX-101 | Mar 26, 1979 | Substantially Equivalent |
| K781976 | MOBILE X-RAY UNIT | Dec 4, 1978 | Substantially Equivalent |
| K781675 | X-RAY COLLIMATOR | Dec 4, 1978 | Substantially Equivalent |
| K781975 | MOBILE CARRIER | Dec 4, 1978 | Substantially Equivalent |