510(k) K111445 ยท KPS System, Tomography, Computed, Emission
DISCOVERY NM 630
| Applicant | GE Healthcare, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Jun 3, 2011 |
| Received | May 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111445
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2025 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Healthcare Discovery NM 630, Model/Catalog Numbers:
1) 5376204-30-2,
2) H2401CF,
3) H2401CH,
4) H2401JE,
5) H3100JY; System, Tomography, Computed, Emission Open, Classified |
KPS | None listed |
| Feb 8, 2023 | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING GE Nuclear Medicine 600/800 series systems, specifically:
a) 830,
b) 830 / Dismount,
c) 830 /,
d) 830 / 5842894-20,
e) 830 / Dismount / 50HZ,
f) 830 / Dismount / 60HZ,
g) 830 3/8 inch Detector Open, Classified |
KPS | None listed |
| Dec 10, 2020 | GE Healthcare, LLC Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detect Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC Discovery NM 630
Model # H3101RH Terminated |
KPS | None listed |
| Aug 14, 2020 | GE Healthcare, LLC NM 830
Model # H3910AC Terminated |
KPS | None listed |
| Mar 20, 2019 | GE Healthcare, LLC Discovery NM 630
Product Usage:
The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope trac Terminated |
JAK | None listed |
| Nov 20, 2013 | GE Healthcare, LLC GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615.
The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professio Terminated |
KPS | None listed |
| Jul 24, 2013 | GE Healthcare, LLC Discovery NM 630, dual detector free-geometry integrated nuclear imaging system.
Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcar Terminated |
KPS | None listed |
| Oct 23, 2012 | GE Healthcare, LLC GE Discovery NM/CT670; GE Discovery NM 630
Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases a Terminated |
KPS | None listed |
| Feb 27, 2012 | GE Healthcare, LLC GE Discovery NM 630
The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.