The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Collimator, Heart Contour.
| Device ID | K781984 |
| 510k Number | K781984 |
| Device Name: | COLLIMATOR, HEART CONTOUR |
| Classification | Device, Beam Limiting, X-ray, Diagnostic |
| Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPW |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-24 |
| Decision Date | 1978-12-04 |