AccessGUDID - DEVICE: Rapid (B761R60)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid
Version or Model: 6.x
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ischemaview, Inc.

Primary DI Number: B761R60
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079477740 *Terms of Use

Device Description: Rapid Platform plus cleared indications for Rapid version 6.x

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QIH	Automated Radiological Image Processing Software
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
LLZ	System, Image Processing, Radiological
QAS	Radiological Computer-Assisted Triage And Notification Software
QFM	Radiological Computer-Assisted Prioritization Software For Lesions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193087	000
K200760	000
K200941	000
K220499	000
K221248	000
K221456	000
K223396	000
K230074	000
K232156	000
K232436	000
K233512	000
K233582	000
K243350	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 34196a84-2c45-43bc-8dac-613175a30a81
Public Version Date: May 15, 2025
Public Version Number: 1
DI Record Publish Date: May 07, 2025

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 303-704-2511
Email: rosa@ischemaview.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES