K020860 is an FDA 510(k) clearance for the M3 (MICRO-MULTILEAF COLLIMATOR). This device is classified as a Accelerator, Linear, Medical (Class II - Special Controls, product code IYE).
Submitted by Brainlab AG (Heimstetten, DE). The FDA issued a Cleared decision on June 6, 2002, 80 days after receiving the submission on March 18, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K020860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 2002 |
| Decision Date | June 06, 2002 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYE — Accelerator, Linear, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |