FDA 510(k)
Substantially Equivalent
🇺🇸 United States
COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100
K Number: K828669
·
Decision Jan 14, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
11
Review Days
45
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100
- K Number
- K828669
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Imatron, Inc.
- Date Received
- November 30, 1982
- Decision Date
- January 14, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- Third Party
- N
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 |
| K913352 | C-150 ULTRAFAST CT SCANNER | Nov 29, 1991 | 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 |