The following data is part of a premarket notification filed by I.s.g. Technologies, Inc. with the FDA for Id. Store (release 2.0).
| Device ID | K973413 |
| 510k Number | K973413 |
| Device Name: | ID. STORE (RELEASE 2.0) |
| Classification | Device, Digital Image Storage, Radiological |
| Applicant | I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD Mississauga, Ontario, CA L4v 1s7 |
| Contact | Carol Nakagawa |
| Correspondent | Carol Nakagawa I.S.G. TECHNOLOGIES, INC. 6509 AIRPORT ROAD Mississauga, Ontario, CA L4v 1s7 |
| Product Code | LMB |
| CFR Regulation Number | 892.2010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-09 |
| Decision Date | 1997-11-25 |
| Summary: | summary |