IMATRON C-100 ULTRAFAST CT SCANNER— 510(k) K872615
Substantially EquivalentImatron, Inc.
FDA 510(k) clearance K872615 for IMATRON C-100 ULTRAFAST CT SCANNER, Substantially Equivalent on 1987-09-23. Applicant: Imatron, Inc.. Device class: 2.
Clearance details
- Applicant
- Imatron, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Fransisco, CA, US
Recent devices under product code JAK
view allMore clearances from Imatron, Inc.
view all- K001550 — EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM
- K000359 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO
- K992740 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS
- K972903 — IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
- K972879 — ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.