FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-150 ULTRAFAST CT SCANNER
K Number: K913352
·
Decision Nov 29, 1991
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
11
Review Days
126
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Basic Information
- Device Name
- C-150 ULTRAFAST CT SCANNER
- K Number
- K913352
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imatron, Inc.
- Date Received
- July 26, 1991
- Decision Date
- November 29, 1991
- 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 Imatron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001550 | EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR | Dec 11, 2000 | Substantially Equivalent |
| K000359 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO | Mar 17, 2000 | Substantially Equivalent |
| K992740 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS | Nov 9, 1999 | Substantially Equivalent |
| K972903 | IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS | Nov 4, 1997 | Substantially Equivalent |
| K972879 | ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION | Oct 15, 1997 | Substantially Equivalent |
| K874934 | UNIVERSAL EXAMINATION TABLE | Jan 19, 1988 | Substantially Equivalent |
| K872615 | IMATRON C-100 ULTRAFAST CT SCANNER | Sep 23, 1987 | Substantially Equivalent |
| K864046 | C-IOO MOBILE CINE CT UNIT | Nov 10, 1986 | Substantially Equivalent |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | Feb 21, 1984 | Substantially Equivalent |
| K828669 | COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 | Jan 14, 1983 | Substantially Equivalent |