OPTIMA NM/CT 640
FDA 510(k) clearance K121019 · decided 2012-04-19
Clearance details
- K-number
- K121019
- Device name
- OPTIMA NM/CT 640
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2012-04-04
- Decision date
- 2012-04-19
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Com recall (Z-0896-2025) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2025-01-10 |
| GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) recall (Z-1056-2023) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2023-02-08 |
| GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The G recall (Z-0367-2014) | GE Healthcare, LLC | 2013-11-20 |
| Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuc recall (Z-1793-2013) | GE Healthcare, LLC | 2013-07-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |