DEVICE: Standard Imaging PIPSpro Software (00866562000236)

Device Identifier (DI) Information

Standard Imaging PIPSpro Software
v5
In Commercial Distribution
91309
STANDARD IMAGING INC.
00866562000236
GS1

1
788084705 *Terms of Use
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
40887 Radiation therapy software
An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IYE Accelerator, Linear, Medical
IXG Phantom, Anthropomorphic, Radiographic
LHO Instrument, Quality-Assurance, Radiologic
LLZ System, Image Processing, Radiological
LMB Device, Digital Image Storage, Radiological
LMD System, Digital Image Communications, Radiological
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042733 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

186d9f3b-ac9e-4f27-a9e2-131c5d4c8a32
June 16, 2023
4
October 11, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE