Submission Details
| 510(k) Number | K942190 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 1994 |
| Decision Date | August 17, 1994 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K942190 is an FDA 510(k) clearance for the ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Image Diagnostics, Inc. (Sterling, US). The FDA issued a Cleared decision on August 17, 1994, 105 days after receiving the submission on May 4, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K942190 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 1994 |
| Decision Date | August 17, 1994 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXQ — Table, Radiographic, Stationary Top |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1980 |