The following data is part of a premarket notification filed by Advanced Light Imaging Technologies Ltd. with the FDA for Picture Archiving And Communication Systems.
| Device ID | K925965 |
| 510k Number | K925965 |
| Device Name: | PICTURE ARCHIVING AND COMMUNICATION SYSTEMS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED LIGHT IMAGING TECHNOLOGIES LTD. 320-3700 GILMORE WAY BURNABY, B.c. Canada V5g 4m1, CA |
| Contact | Kevin L James |
| Correspondent | Kevin L James ADVANCED LIGHT IMAGING TECHNOLOGIES LTD. 320-3700 GILMORE WAY BURNABY, B.c. Canada V5g 4m1, CA |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-25 |
| Decision Date | 1993-06-14 |