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Rapid ASPECTS

by iSchemaView, Inc.

510(k) K200760

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK200760 Date26 Jun 2020ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
POK
Device class
Class II
Regulation
21 CFR Part 892.2060
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Rapid ASPECTS is computer-assisted diagnostic software for lesions suspicious for cancer. It is designed to assist physicians in the analysis of brain images using automated tools for CT ASPECTS.

The device is supplied as software and is used in radiology settings. It has received FDA 510(k) clearance under K200760 and is classified as a Class II medical device with product code POK.

Devices cleared under K200760

9 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K200760
UDI-DISize and differences
Rapid 5.1.1
iSchemaView, Inc.
Rapid / 5.1.1B7671R511
Prescription: no
On the market
Rapid 5.1.2
iSchemaView, Inc.
Rapid / 5.1.2B7671R512
Prescription: yes
On the market
Rapid 5.2.0
iSchemaView, Inc.
Rapid / 5.2.0B7671R520
Prescription: yes
On the market
Rapid 5.2.2
iSchemaView, Inc.
Rapid / 5.2.2B7671R521
Prescription: yes
On the market
Rapid 5.7
iSchemaView, Inc.
Rapid / 5.7B761R5701
Prescription: yes
On the market
Rapid 5.7.1
iSchemaView, Inc.
Rapid / 5.7.1B761R5711
Prescription: yes
On the market
Rapid 5.7.2
iSchemaView, Inc.
Rapid / 5.7.2B761R5721
Prescription: yes
On the market
Rapid 6.1.0
iSchemaView, Inc.
6.1.0B761R610
Prescription: no
On the market
Rapid 6.x
iSchemaView, Inc.
6.xB761R60
Prescription: yes
On the market

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