The following data is part of a premarket notification filed by Radiological Imaging Technology, Inc. with the FDA for Rit 113 Film Analysis System.
| Device ID | K935928 |
| 510k Number | K935928 |
| Device Name: | RIT 113 FILM ANALYSIS SYSTEM |
| Classification | Accelerator, Linear, Medical |
| 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 | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857450006003 | K935928 | 000 |