DISCOVERY NM 630
FDA 510(k) clearance K111445 · decided 2011-06-03
Clearance details
- K-number
- K111445
- Device name
- DISCOVERY NM 630
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2011-05-24
- Decision date
- 2011-06-03
- Days to decision
- 10 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
+ Add to Predicate Builder ◉ Watch GE Healthcare
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H24 recall (Z-0890-2025) | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | 2025-01-10 |
| GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 83 recall (Z-1054-2023) | 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 |
| Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product U recall (Z-1791-2013) | GE Healthcare, LLC | 2013-07-24 |
| GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use recall (Z-0121-2013) | GE Healthcare, LLC | 2012-10-23 |
| GE Discovery NM 630 The GE Discovery NM 630 system is a medical tool intended for use by a recall (Z-1111-2012) | GE Healthcare, LLC | 2012-02-27 |
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 |