FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR
K Number: K001550
·
Decision Dec 11, 2000
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
207
Basic Information
- Device Name
- EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR
- K Number
- K001550
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IMATRON, INC.
- Date Received
- May 18, 2000
- Decision Date
- December 11, 2000
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by IMATRON, INC.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K828669 | COMPUTED CINETOMOGRAPHY SCANNER, MODEL C-100 | Jan 14, 1983 | Substantially Equivalent |