The following data is part of a premarket notification filed by Quantitative Cardiac Systems (qcs), Inc. with the FDA for Quantim 2000i Digital Image Analysis System.
| Device ID | K892711 |
| 510k Number | K892711 |
| Device Name: | QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | QUANTITATIVE CARDIAC SYSTEMS (QCS), INC. 115 RESEARCH DR. Ann Arbor, MI 48103 |
| Contact | J Allsebrook |
| Correspondent | J Allsebrook QUANTITATIVE CARDIAC SYSTEMS (QCS), INC. 115 RESEARCH DR. Ann Arbor, MI 48103 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-14 |
| Decision Date | 1989-12-14 |