The following data is part of a premarket notification filed by .decimal, Llc. with the FDA for Decimal3d.
| Device ID | K192554 |
| 510k Number | K192554 |
| Device Name: | Decimal3D |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | .decimal, LLC. 121 Central Park PL Sanford, FL 32771 |
| Contact | Kevin Erhart |
| Correspondent | Kevin Erhart .decimal, LLC. 121 Central Park PL Sanford, FL 32771 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-17 |
| Decision Date | 2019-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851147007113 | K192554 | 000 |