Standard Imaging DoseView 1d

Standard Imaging DoseView 1D fulfills the requirements set forth by the AAPM TG-51 Protocol for a single dimension water scanning phantom. Determining the depth-dose curve and Source to…

Registry build 21.09.26

Standard Imaging DoseView 1D fulfills the requirements set forth by the AAPM TG-51 Protocol for a single dimension water scanning phantom. Determining the depth-dose curve and Source to Axis Distance (SAD) measurements are easily done with the system.

3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

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 Standard Imaging DoseView 1D
Listed by Standard Imaging, Inc., United States
FDA product code LHO
Device type Instrument, Quality-Assurance, Radiologic
Device class Class 1
Regulation 21 CFR 892.1940
Establishment Contract manufacturer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-06-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Standard Imaging DoseView 1D
Catalogue number Size Status
70800 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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K042733 2004-11-15

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