The following data is part of a premarket notification filed by I.z.i. Corp. with the FDA for Mri Line Marker.
| Device ID | K014022 |
| 510k Number | K014022 |
| Device Name: | MRI LINE MARKER |
| Classification | Accelerator, Linear, Medical |
| Applicant | I.Z.I. CORP. 7020 TUDSBURY RD. Baltimore, MD 21244 |
| Contact | Helen Zinreich |
| Correspondent | Helen Zinreich I.Z.I. CORP. 7020 TUDSBURY RD. Baltimore, MD 21244 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-06 |
| Decision Date | 2002-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212022869 | K014022 | 000 |
| 10815212020268 | K014022 | 000 |
| 00815212020261 | K014022 | 000 |
| 00815212020278 | K014022 | 000 |
| 00815212020704 | K014022 | 000 |
| 00815212020711 | K014022 | 000 |
| 00815212020728 | K014022 | 000 |
| 00815212020735 | K014022 | 000 |
| 00815212020742 | K014022 | 000 |
| 00815212020759 | K014022 | 000 |
| 00815212020766 | K014022 | 000 |
| 00815212020773 | K014022 | 000 |
| 00815212021664 | K014022 | 000 |
| 00815212022753 | K014022 | 000 |
| 00815212022777 | K014022 | 000 |
| 00815212022784 | K014022 | 000 |
| 00815212022845 | K014022 | 000 |
| 10815212026673 | K014022 | 000 |