FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CT BLANKETS (BOLUS MATERIAL)
K Number: K780737
·
Decision Jun 2, 1978
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
13
Review Days
32
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Basic Information
- Device Name
- CT BLANKETS (BOLUS MATERIAL)
- K Number
- K780737
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Emi Medical, Inc.
- Date Received
- May 1, 1978
- Decision Date
- June 2, 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 |
| K780928 | CT5137 HIGH RESOLUTION OPTION | Jun 14, 1978 | Substantially Equivalent |
| K780930 | 5543 INDEPENDENT VIEWING SYSTEM | Jun 14, 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 |