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Rapid 5.1.1

by iSchemaView, Inc.

Rapid 5.1.1 is a radiological PACS-dedicated management software (FDA Class II) made by iSchemaView, Inc., cleared under FDA 510(k) K200941 on 9 Jul 2020 (3 earlier submissions) and listed in FDA GUDID since 25 May 2022 (UDI-DI B7671R511), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB7671R511 UDI-DI Date25 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200941 Date9 Jul 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200941 decided 9 Jul 2020 Active· +3 more in the status table
  • FDA GUDID UDI-DI B7671R511 listed 25 May 2022 Listed

Timeline

5 dated events

  1. Cleared FDA 510(k) K182130
  2. Cleared FDA 510(k) K193087
  3. Cleared FDA 510(k) K200760
  4. Cleared FDA 510(k) K200941
  5. Listed FDA GUDID B7671R511

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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
5.1.1, Rapid
Primary DI / UDI-DI
B7671R511
510(k) Number
FDA product code
POK, QAS, LLZ
GMDN term
Radiological PACS-dedicated management software
Device class
Class II
Regulation number
892.2060, 892.2080, 892.2050
GUDID distribution status
In Commercial Distribution

Related devices

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 in this category

Other devices filed under Radiological PACS software.

Other devices from iSchemaView, Inc.

See all devices from iSchemaView, Inc. →

Properties

  • Single use
Other properties (14, all answered No)