The following data is part of a premarket notification filed by Image Diagnostics, Inc. with the FDA for Multiple Ed1600 Series Radiation Shields.
| Device ID | K944772 |
| 510k Number | K944772 |
| Device Name: | MULTIPLE ED1600 SERIES RADIATION SHIELDS |
| Classification | Screen, Leaded, Operator Radiation Protector |
| Applicant | IMAGE DIAGNOSTICS, INC. 98 PRATTS JUNCTION RD. Sterling, MA 01564 |
| Contact | Remo J Rossi |
| Correspondent | Remo J Rossi IMAGE DIAGNOSTICS, INC. 98 PRATTS JUNCTION RD. Sterling, MA 01564 |
| Product Code | EAK |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-10-20 |