CELESTEION, PCA-9000A/2— 510(k) K140651
Substantially EquivalentToshibamedical Systems Corporation
FDA 510(k) clearance K140651 for CELESTEION, PCA-9000A/2, Substantially Equivalent on 2014-06-11. Applicant: Toshibamedical Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Toshibamedical Systems Corporation
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Recent devices under product code KPS
view allMore clearances from Toshibamedical Systems Corporation
view allRecalls naming K140651
K-number listed on FDA's recall record- Z-1607-2016 — Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.
- Z-0005-2016 — Celesteion PCA-9000A/2 PET/CT System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140651.
Data sourced from openFDA. This site is unofficial and independent of the FDA.