PRIMELUNG
System, X-ray, Tomography, Computed
ACCUIMAGE DIAGNOSTICS CORP.
The following data is part of a premarket notification filed by Accuimage Diagnostics Corp. with the FDA for Primelung.
Pre-market Notification Details
| Device ID | K024149 |
| 510k Number | K024149 |
| Device Name: | PRIMELUNG |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | ACCUIMAGE DIAGNOSTICS CORP. 400 GRANDVIEW DR. South San Francisco, CA 94080 |
| Contact | Oscar G Carbo |
| Correspondent | Oscar G Carbo ACCUIMAGE DIAGNOSTICS CORP. 400 GRANDVIEW DR. South San Francisco, CA 94080 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-02-21 |
| Summary: | summary |
Trademark Results [PRIMELUNG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRIMELUNG 78184787 2907209 Dead/Cancelled |
CEDARA SOFTWARE (USA) LIMITED 2002-11-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.