Geometric QA Phantom

The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric…

Registry build 21.09.26

The Geometric Quality Assurance Phantom is intended to provide the operator with spatial reference information that can aid the operator to assess whether or not the amount of geometric distortions of the MR scanner is acceptable for the intended application.

3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Beijing (2), Jiangsu (1).

Chinese manufacturers registered for FDA product code LHO
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Nanjing Jusha Display Technology Co., Ltd. Nanjing Jiangsu Manufacturer 7

Record

Regulatory record for Geometric QA Phantom
Listed by Philips Healthcare Group, United States
FDA product code LHO
Device type Instrument, Quality-Assurance, Radiologic
Device class Class 1
Regulation 21 CFR 892.1940
Premarket notification Exempt
Record published 2016-09-23
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety MR Safe
Prescription Prescription only
Label carries serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Geometric QA Phantom
Catalogue number Size Status
459800438932 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Quasar Modus Medical Devices, Inc. 93
Easy Cube L A P Gmbh Laser Applikationen 91
KermaX-plus IBA Dosimetry GmbH 74
Easy Slab L A P Gmbh Laser Applikationen 68
Instrument, Quality-Assurance, Radiologic PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 45
Diamentor PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 42
Octavius PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 16
RW3 slab phantom PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 13
Vista Modus Medical Devices, Inc. 13
Ruby PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 10
MP1 Manual Water Phantom PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 10
Couchfix PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 7

Showing 12 of 163. All products under Instrument, Quality-Assurance, Radiologic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer