Rapid 6.1.0: FDA 510(k) K230074 cleared 2023

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB761R610 UDI-DI	Date13 Feb 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK230074	Date27 Jul 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK222884	Date2 Mar 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK223396	Date1 Feb 2023Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK221456	Date12 Sep 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK221248	Date31 May 2022Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK220499	Date17 May 2022Decided	StatusActive
United States	FDA 510(k) from GUDID	NumberK213165	Date8 Feb 2022Issued	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200941	Date9 Jul 2020Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200760	Date26 Jun 2020Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK193087	Date31 Mar 2020Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K230074
FDA 510(k) database 510(k) number K222884
FDA 510(k) database 510(k) number K223396
FDA 510(k) database 510(k) number K221456
FDA 510(k) database 510(k) number K221248
FDA 510(k) database 510(k) number K220499
FDA 510(k) database 510(k) number K213165
FDA 510(k) database 510(k) number K200941
FDA 510(k) database 510(k) number K200760
FDA 510(k) database 510(k) number K193087

Across registries

2 registries list this device

FDA 510(k) K230074 decided 27 Jul 2023 Active· +9 more in the status table
FDA GUDID UDI-DI B761R610 listed 13 Feb 2024 Listed

Timeline

11 dated events

26 Jun 2020 Cleared FDA 510(k) K200760
9 Jul 2020 Cleared FDA 510(k) K200941
8 Feb 2022 Cleared FDA 510(k) K213165
17 May 2022 Cleared FDA 510(k) K220499
31 May 2022 Cleared FDA 510(k) K221248
12 Sep 2022 Cleared FDA 510(k) K221456
1 Feb 2023 Cleared FDA 510(k) K223396
2 Mar 2023 Cleared FDA 510(k) K222884
27 Jul 2023 Cleared FDA 510(k) K230074
13 Feb 2024 Listed FDA GUDID B761R610

1 earlier event are in the sections above.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Rapid
Generic name: Radiological PACS-dedicated management software
Model / reference: 6.1.0

Primary DI / UDI-DI: B761R610
510(k) Number: K193087
K200760
K200941
K213165
K220499
K221248
K221456
K222884
K223396
K230074
FDA product code: LLZ, QAS, POK, QIH, QFM
GMDN term: Radiological PACS-dedicated management software

Device class: Class II
Regulation number: 892.2050, 892.2080, 892.2060
GUDID distribution status: In Commercial Distribution

Category: Radiological PACS software

Cleared under the same submission (K193087)

and 4 more cleared under K193087

Cleared under the same submission (K200760)

and 4 more cleared under K200760

Similar devices

Also classified as Radiological PACS software.

AVIEW 1.1 — CORELINE SOFT CO., LTD. Class II
ThinkingNet 06 — THINKING SYSTEMS CORP. Class II
IMAGEGRID RADIOLOGY VIEWER SYSTEM IG-2B — Candelis, Inc. Class II
EAGLESOFT 21.20 — PATTERSON TECHNOLOGY CENTER Class II
QuantX Breast MRI Biopsy Guidance Plugin — Qlarity Imaging Class II

Similar devices in this category

Other devices filed under Radiological PACS software.

Other devices from iSchemaView, Inc.

Rapid Vessel Occlusion (Rapid VO)

Class II
Rapid ICH (v4.0)

Class II
Rapid Platform (R6.7)

Class II
Rapid 5.7.1

Class II

See all devices from iSchemaView, Inc. →

Properties

Single use

Other properties (14, all answered No)