The following data is part of a premarket notification filed by Moksha Digital Software Pvt Limited with the FDA for Curiepacs (dicom Pacs Software).
| Device ID | K102148 |
| 510k Number | K102148 |
| Device Name: | CURIEPACS (DICOM PACS SOFTWARE) |
| Classification | System, Image Processing, Radiological |
| Applicant | MOKSHA DIGITAL SOFTWARE PVT LIMITED #1611, JANARDHANA TOWERS 7TH CROSS, 19TH MAIN, SECTOR 1 Hsr Layout, Bangalore, IN 560034 |
| Contact | Deepak Sharma |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-07-30 |
| Decision Date | 2010-08-17 |
| Summary: | summary |