The following data is part of a premarket notification filed by Arcoma Ab with the FDA for Intuition, Model 0170.
| Device ID | K073632 |
| 510k Number | K073632 |
| Device Name: | INTUITION, MODEL 0170 |
| Classification | System, X-ray, Stationary |
| Applicant | ARCOMA AB ANNAVAGEN 1 Vaxjo, SE S-352 46 |
| Contact | Bengt-hugo Johansson |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-01-10 |
| Summary: | summary |