The following data is part of a premarket notification filed by Ricoh Usa, Inc. with the FDA for 3d Anatomic Models.
| Device ID | K220205 |
| 510k Number | K220205 |
| Device Name: | 3D Anatomic Models |
| Classification | System, Image Processing, Radiological |
| Applicant | Ricoh USA, Inc. 5575 Venture Drive Unit A Parma, OH 44130 |
| Contact | Gary Turner |
| Correspondent | Scott Brewer Ricoh USA, Inc. 5575 Venture Drive Unit A Parma, OH 44130 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-25 |
| Decision Date | 2022-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G003DM01 | K220205 | 000 |