The following data is part of a premarket notification filed by Columbia Scientific, Inc. with the FDA for Imagemaster-101(tm).
| Device ID | K897000 |
| 510k Number | K897000 |
| Device Name: | IMAGEMASTER-101(TM) |
| Classification | System, Image Processing, Radiological |
| Applicant | COLUMBIA SCIENTIFIC, INC. 8940-K OLD ANNAPOLIS RD. Columbia, MD 21045 |
| Contact | D Stockham |
| Correspondent | D Stockham COLUMBIA SCIENTIFIC, INC. 8940-K OLD ANNAPOLIS RD. Columbia, MD 21045 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-23 |