Model 1300GE-64: Pediatric Positioner
FDA 510(k) K030317 · Midwest Rf, LLC
510(k) numberK030317
Submission
- Device name
- Model 1300GE-64: Pediatric Positioner
- Applicant
- Midwest Rf, LLC
Hartland, WI, US - Received
- January 30, 2003
- Decision date
- March 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MOS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | Philips Medical Systems Nederland B.V. | 07/30/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | Philips Medical Systems Nederland B.V. | 07/24/2026SE |
| K260947 | 0.55T 12Ch Breast CoilMOS · Special | Neocoil, LLC | 04/23/2026SE |
| K252587 | HD 8Ch Wrist ArrayMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/14/2026SE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/01/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | Philips Healthcare (Suzhou) Co., Ltd. | 03/20/2026SE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 02/10/2026SE |
| K253738 | 3.0T Air 32CH HnaMOS · Abbreviated | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/23/2026SE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | Philips Medical Systems Nederland B.V. | 01/14/2026SE |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special | Inkspace Imaging, Inc. | 10/20/2025SE |
More from Inkspace Imaging, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K111259 | SV DBS Vrain ArrayMOS · Traditional | 07/05/2011SE |
| K091496 | MEP-90 Hair Growth Stimulation SystemOAP · Traditional | 02/23/2010SE |
| K090267 | SV DBS Brain Array, Model 1500SV-SMS64MOS · Traditional | 03/16/2009SE |
| K051618 | Special Procedures II Head Coil, Model 1400GE-64MOS · Traditional | 08/02/2005SE |
| K003386 | Special Procedures Head Coil; Model # 1100GE-64MOS · Traditional | 12/28/2000SE |
| K003097 | Brain Coil, Model 9800GE-64MOS · Traditional | 12/28/2000SE |
| K002860 | Model 6900GE-64: C-Spine ArrayMOS · Traditional | 11/22/2000SE |
| K002864 | Model 6600GE-64: Trama Neck ArrayMOS · Traditional | 11/21/2000SE |
Questions and answers
When was Model 1300GE-64: Pediatric Positioner cleared by the FDA?
Model 1300GE-64: Pediatric Positioner (K030317) received a 510(k) decision of Substantially Equivalent on March 25, 2003, 54 days after the submission was received.
What is the product code of K030317?
The FDA product code is MOS – Coil, Magnetic Resonance, Specialty, a Class II (moderate risk) device regulated under 21 CFR 892.1000.