Rapid 5.7: FDA 510(k) K221456 cleared 2022

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB761R5701 UDI-DI	Date29 Jun 2023Listed	StatusListed GUDID: in commercial distribution
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	NumberK200760	Date26 Jun 2020Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK193087	Date31 Mar 2020Decided	StatusActive
United States	FDA 510(k) from GUDID	NumberK182130	Date27 Dec 2018Issued	StatusActive

Official records

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 K200760
FDA 510(k) database 510(k) number K193087
FDA 510(k) database 510(k) number K182130

Across registries

2 registries list this device

FDA 510(k) K221456 decided 12 Sep 2022 Active· +6 more in the status table
FDA GUDID UDI-DI B761R5701 listed 29 Jun 2023 Listed

Timeline

8 dated events

27 Dec 2018 Cleared FDA 510(k) K182130
31 Mar 2020 Cleared FDA 510(k) K193087
26 Jun 2020 Cleared FDA 510(k) K200760
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
29 Jun 2023 Listed FDA GUDID B761R5701

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Withdrawn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 / Ref / Catalog: 5.7, Rapid

Primary DI / UDI-DI: B761R5701
510(k) Number: K182130
K193087
K200760
K213165
K220499
K221248
K221456
FDA product code: LLZ, QAS, POK
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 (K182130)

and 4 more cleared under K182130

Cleared under the same submission (K193087)

and 4 more cleared under K193087

Similar devices

Also classified as Radiological PACS software.

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Other devices filed under Radiological PACS software.

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Properties

Single use
Prescription use

Other properties (13, all answered No)