The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Precise Carbon Fiber Table Top, Model 11-999.
| Device ID | K032248 |
| 510k Number | K032248 |
| Device Name: | PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 |
| Classification | Accelerator, Linear, Medical |
| Applicant | AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Contact | Tony Spaccarotella |
| Correspondent | Tony Spaccarotella AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers, NY 10920 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-22 |
| Decision Date | 2003-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B365603120 | K032248 | 000 |
| B365112130 | K032248 | 000 |
| B365112120 | K032248 | 000 |
| B365112110 | K032248 | 000 |
| B365112020 | K032248 | 000 |
| B365539880 | K032248 | 000 |
| B365512600 | K032248 | 000 |
| B365512500 | K032248 | 000 |
| B365512300 | K032248 | 000 |
| B365512250 | K032248 | 000 |
| B365512200 | K032248 | 000 |
| B365512150 | K032248 | 000 |
| B365512010 | K032248 | 000 |
| B365114710 | K032248 | 000 |
| B365112140 | K032248 | 000 |
| B365112150 | K032248 | 000 |
| B365112170 | K032248 | 000 |
| B365603110 | K032248 | 000 |
| B365603100 | K032248 | 000 |
| B365601900 | K032248 | 000 |
| B365512000 | K032248 | 000 |
| B365114700 | K032248 | 000 |
| B365114690 | K032248 | 000 |
| B365114670 | K032248 | 000 |
| B365114660 | K032248 | 000 |
| B36511465BR0 | K032248 | 000 |
| B365114650 | K032248 | 000 |
| B365114630 | K032248 | 000 |
| B365114620 | K032248 | 000 |
| B365112200 | K032248 | 000 |
| B365112230 | K032248 | 000 |