The following data is part of a premarket notification filed by Radiological Imaging Technology, Inc. with the FDA for Rit 531 Teleradiology/ Pac System.
Device ID | K944130 |
510k Number | K944130 |
Device Name: | RIT 531 TELERADIOLOGY/ PAC SYSTEM |
Classification | System, Digital Image Communications, Radiological |
Applicant | RADIOLOGICAL IMAGING TECHNOLOGY, INC. 5385 SETTERS WAY Colorado Springs, CO 80919 |
Contact | Daniel M Ritt |
Correspondent | Daniel M Ritt RADIOLOGICAL IMAGING TECHNOLOGY, INC. 5385 SETTERS WAY Colorado Springs, CO 80919 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-24 |
Decision Date | 1994-12-23 |