FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CT5137 HIGH RESOLUTION OPTION
K Number: K780928
·
Decision Jun 14, 1978
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
795
Applicant Total
13
Review Days
9
Basic Information
- Device Name
- CT5137 HIGH RESOLUTION OPTION
- K Number
- K780928
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- EMI MEDICAL, INC.
- Date Received
- June 5, 1978
- Decision Date
- June 14, 1978
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by EMI MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K791429 | EMISONIC 4290 | Sep 21, 1979 | Substantially Equivalent |
| K781936 | SCANNER-EMI 7020 AND 7020R | Dec 4, 1978 | Substantially Equivalent |
| K781519 | EMI SIMULATOR REMOTE CONTROL CONSOLE | Sep 14, 1978 | Substantially Equivalent |
| K781051 | EMISONIC 4201 | Jul 17, 1978 | Substantially Equivalent |
| K780995 | COMPUTERIZED AXIAL TOMOGRAPHY | Jun 22, 1978 | Substantially Equivalent |
| K780930 | 5543 INDEPENDENT VIEWING SYSTEM | Jun 14, 1978 | Substantially Equivalent |
| K780737 | CT BLANKETS (BOLUS MATERIAL) | Jun 2, 1978 | Substantially Equivalent |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | Jun 2, 1978 | Substantially Equivalent |
| K771978 | CTR 100L | Nov 23, 1977 | Substantially Equivalent |
| K772125 | TOMOGRAPHIC SCANNER, COMPUTERIZED | Nov 21, 1977 | Substantially Equivalent |