The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Innova Igs 5, Innova Igs 6, Discovery Igs 7, Discovery Igs 7 Or.
| Device ID | K181403 |
| 510k Number | K181403 |
| Device Name: | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE Healthcare 283 Rue De La Miniere Buc, FR 78530 |
| Contact | Michel Genuer |
| Correspondent | Michel Genuer GE Healthcare 283 Rue De La Miniere Buc, FR 78530 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682141284 | K181403 | 000 |
| 00840682124638 | K181403 | 000 |
| 00840682125888 | K181403 | 000 |
| 00195278524904 | K181403 | 000 |
| 00195278524911 | K181403 | 000 |
| 00195278485144 | K181403 | 000 |
| 00195278485168 | K181403 | 000 |
| 00195278215543 | K181403 | 000 |
| 00195278215550 | K181403 | 000 |
| 00840682141307 | K181403 | 000 |
| 00840682147378 | K181403 | 000 |
| 00840682124614 | K181403 | 000 |