The following data is part of a premarket notification filed by Markcare Medical Systems, Inc. with the FDA for Intrascan Ii.
| Device ID | K944771 |
| 510k Number | K944771 |
| Device Name: | INTRASCAN II |
| Classification | System, Digital Image Communications, Radiological |
| Applicant | MARKCARE MEDICAL SYSTEMS, INC. 87 ROUTE 17 NORTH Maywood, NJ 07607 |
| Contact | John A Reiling |
| Correspondent | John A Reiling MARKCARE MEDICAL SYSTEMS, INC. 87 ROUTE 17 NORTH Maywood, NJ 07607 |
| Product Code | LMD |
| CFR Regulation Number | 892.2020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1995-01-26 |