The following data is part of a premarket notification filed by Merge Healthcare Incorporated with the FDA for Ibm Iconnect Access.
| Device ID | K182290 |
| 510k Number | K182290 |
| Device Name: | IBM IConnect Access |
| Classification | System, Image Processing, Radiological |
| Applicant | Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, WI 53209 |
| Contact | Tracey Fox |
| Correspondent | Tracey Fox Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, WI 53209 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2018-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100720 | K182290 | 000 |
| 00842000100782 | K182290 | 000 |
| 00842000100843 | K182290 | 000 |
| 00842000100980 | K182290 | 000 |
| 90842000100914 | K182290 | 000 |
| 00842000101024 | K182290 | 000 |
| 00842000101017 | K182290 | 000 |