The following data is part of a premarket notification filed by Lifetrack Medical Systems, Inc. with the FDA for Lifesys Pacs.
| Device ID | K161341 |
| 510k Number | K161341 |
| Device Name: | LIFESYS PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | LIFETRACK MEDICAL SYSTEMS, INC. 1007 ONE WORLD PLACE, 32ND STREET, BGC Taguig City, PH 1634 |
| Contact | Eric Schulze |
| Correspondent | Keith Barritt FISH & RICHARDSON 1425 K STREET NW Washington, DC 20005 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-13 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B581LIFESYSPACSV20 | K161341 | 000 |