510(k) · Cleared

Cleared

Verista Imaging Isocam II Gamma Camera

K081757510(k) SpecialCleared Aug 15, 200856-day reviewClass I21 CFR 892.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Verista Imaging, Inc. · IYX Camera, Scintillation (Gamma)

Cleared on Aug 15, 2008 as substantially equivalent to K940487 (Independent Scintilation Imaging Systems, Inc., 1994) and 2 other predicates after a 56-day review. Its family tree reaches back 1 generation to 1994.

Decided: Aug 15, 2008
Review: 56 days
Class: Class I
Product code: IYX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K940487 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK940487 Isocam II (Dual Head Gamma Camera)Independent Scintilation Imaging Systems, Inc. · 1994
This deviceK081757 Verista Imaging Isocam II Gamma CameraVerista Imaging, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K940487	Isocam II (Dual Head Gamma Camera)	Independent Scintilation Imaging Systems, Inc.	1994	—
0 (this device)	K081757	Verista Imaging Isocam II Gamma Camera	Verista Imaging, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K081757, 1994–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYX device

#1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K940487	Isocam II (Dual Head Gamma Camera) Summary page 1 …he Device: Verista Imaging ISOCAM IIGamma Camera 3. Common or Usual Name: Scintillation (Gamma Camera) 4. Predicate Device Information: K940487, ISOCAM II (Dual Head Gamma Camera), Independent Scintillation Imaging Systems, Inc. K964834, ISO…	Independent Scintilation Imaging Systems, Inc.	1994	—
*	K964834	Isocam II (Dual Head Gamma Camera) Summary page 1 …Predicate Device Information: K940487, ISOCAM II (Dual Head Gamma Camera), Independent Scintillation Imaging Systems, Inc. K964834, ISOCAM II (Dual Head Gamma Camera), Park Medical Systems, Inc., Lachine, Quebec, Canada K970128,…	Park Medical Systems, Inc.	1997	—
*	K970128	Isocam I (Single Head Gamma Camera)/Isocam II (Dual Head Gamma Camera) Summary page 1 …Imaging Systems, Inc. K964834, ISOCAM II (Dual Head Gamma Camera), Park Medical Systems, Inc., Lachine, Quebec, Canada K970128, ISOCAM I (Single Head Gamma Camera)/ISOCAM II (Dual Head Gamma Camera), Park Medical Systems, Inc.,…	Park Medical Systems, Inc.	1997	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 3 ancestors has a recall.

How does its category compare?

All IYX devices

IYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · IYX

2in 2023

2007high 4 (2010) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYX

82in 2011

2007high 82 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYX

2in 2025

2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYX

1in 2022

2007high 11 (2007) · low 0 (2017)2025

MAUDE reports naming product code IYX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	11
2008	2	—	0	10
2009	2	—	0	8
2010	4	82	0	5
2011	3	82	0	6
2012	0	—	0	1
2013	1	—	0	1
2014	1	—	0	3
2015	0	—	0	4
2016	2	—	0	2
2017	1	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	1
2023	2	—	0	0
2024	0	—	0	0
2025	0	—	2	0
2026	0	—	0	—

What is it indicated for?

Verista Imaging ISOCAM II Gamma Camera is intended to image the distribution of radionuclides in the body by means of photon radiation detector(s).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081757 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081757: Verista Imaging Isocam II Gamma Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081757

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026